<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04469010</url>
  </required_header>
  <id_info>
    <org_study_id>9BN1</org_study_id>
    <nct_id>NCT04469010</nct_id>
  </id_info>
  <brief_title>Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being</brief_title>
  <official_title>Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being in Non-anaemic Iron Deficient and Iron Sufficient Women of Reproductive Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Iron deficiency is the most prevalent nutritional deficiency worldwide with one in four&#xD;
      estimated to be affected by iron deficiency anaemia. Women of reproductive age are at&#xD;
      greatest risk for iron deficiency and anaemia due to iron losses during menstruation and&#xD;
      childbirth as well as the increased need for iron throughout pregnancy. However, iron&#xD;
      deficiency without anaemia is at least twice as common as iron deficiency anaemia with&#xD;
      females aged 11-49 at the biggest risk of all. Despite this, it is commonly left undiagnosed.&#xD;
      Those who are iron deficient non-anaemic can still suffer from the same common consequences&#xD;
      of iron deficiency anaemia; these include unexplained fatigue, mood changes and decreased&#xD;
      cognitive performance. However, randomised controlled trials (RCTs) assessing the effect of&#xD;
      iron supplementation upon cognitive performance, mood, fatigue and well-being in non-anaemic&#xD;
      iron deficient women of reproductive age are limited. There is also a lack of well-defined&#xD;
      diagnostic criteria for non-anaemic iron deficiency, which makes comparisons across RCTs&#xD;
      difficult. However, there is evidence to suggest that a haemoglobin cut off of ≥120 g/L and&#xD;
      serum ferritin ≤ 20 µg/L provides an accurate indication of non-anaemic iron deficiency in&#xD;
      women of reproductive age; this is inclusive of the ability to recognise iron-associated&#xD;
      deficits in psychological and physiological functioning. Additionally, previous RCTs could be&#xD;
      improved by utilising a lower dose of iron in a bis-glycinate chelate form, which is&#xD;
      evidenced to have superior bioavailability, tolerability and subsequent efficacy compared to&#xD;
      ferrous formulations. Iron bis-glycinate absorption is also negatively associated to serum&#xD;
      ferritin levels, which is suggestive of a non-anaemic iron deficient population benefitting&#xD;
      most from it's administration. The current study aims to build upon previous iron RCTs in&#xD;
      populations of non-anaemic iron deficient and iron sufficient women of reproductive age by&#xD;
      investigating the effects of 16-weeks supplementation with either iron bis-glycinate chelate&#xD;
      alone, iron bis-glycinate plus vitamin C (as ascorbic acid) or matched placebo upon cognitive&#xD;
      performance, subjective mood, fatigue, health and well-being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each participant will be required to attend the laboratory on four occasions. The first is&#xD;
      comprised of a screening/training visit, which will take place in the afternoon for&#xD;
      approximately 2.5 hours. This will also be between days 21-28/ the week before onset of their&#xD;
      menstrual cycle. If they do not have menstrual bleeds then this appointment can be any&#xD;
      afternoon. This will comprise: briefing of requirements of the study; obtaining of informed&#xD;
      consent; confirmation of eligibility to take part, including collection of demographic data&#xD;
      and health screening, and training on the cognitive and mood measures. The training session&#xD;
      will follow standard operating procedures to decrease the chance of learning effects during&#xD;
      main trials. Extra training will be given where necessary.&#xD;
&#xD;
      Participants will be required to complete questionnaires based upon food frequency, caffeine&#xD;
      consumption and to estimate the number of hours of exercise completed on a weekly basis. A&#xD;
      menstrual cycle questionnaire will also be completed to estimate menstrual blood loss and so&#xD;
      that participants attend their testing visit during days 7-14 of their cycle. If participants&#xD;
      do not have a menstrual cycle due to contraceptive methods, then appointments will be&#xD;
      approximately two weeks apart. A finger-prick and venous blood sample will be collected from&#xD;
      participants, which will be analysed for iron status. Those whose haemoglobin levels are&#xD;
      &lt;120g/L will be advised to seek advice from their GP. Participants who fell into the iron&#xD;
      status category of iron sufficient (haemoglobin ≥120 g/L and serum ferritin &gt; 20 µg/L) or&#xD;
      non-anaemic iron deficient (haemoglobin ≥120 g/L and serum ferritin ≤ 20 µg/L) will be&#xD;
      informed of their eligibility for the intervention study by email or phone between the&#xD;
      initial visit and their next.&#xD;
&#xD;
      For the testing visit, participants will be asked to fast for 12 hours prior to the visit,&#xD;
      avoiding intake of all food and drink with the exception of water. They will also be asked to&#xD;
      avoid alcohol and refrain from intake of 'over the counter' medication for 24 hours.&#xD;
      Participants will arrive at the laboratory at a designated time in the morning. The following&#xD;
      procedures will take place prior to cognitive and mood testing:&#xD;
&#xD;
        -  Review of continued conformity to eligibility criteria&#xD;
&#xD;
        -  Adverse event and concomitant medication assessment&#xD;
&#xD;
        -  Ensure that participant is in good health Participants will then complete the baseline&#xD;
           cognitive and mood assessments. Following this, participants are informed of their iron&#xD;
           status and will be briefed regarding the requirements of the intervention study.&#xD;
           Following this, informed consent will be obtained prior to randomising participants to&#xD;
           one of three treatments and providing them with a treatment diary to log treatment&#xD;
           consumption and any adverse events experienced.&#xD;
&#xD;
      Participants will return to the laboratory after 8 weeks to exchange treatment bottles and&#xD;
      diaries in order to check compliance.&#xD;
&#xD;
      Participants will finally return to the laboratory after a further 8 weeks (16 weeks total).&#xD;
      The same procedures will take place prior to cognitive and mood testing as completed at the&#xD;
      baseline testing visit, with the addition of finger prick and venous blood sample and weight&#xD;
      measurement. Participants will then complete the same cognitive and mood assessments as&#xD;
      completed during the baseline testing visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Actual">July 19, 2019</completion_date>
  <primary_completion_date type="Actual">July 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will receive either iron and vitamin C, iron alone or placebo for a period of 16 weeks to consume daily</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speed of attention</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for Speed of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time correct reaction time + ZRapid visual information processing correct reaction time + ZDigit vigilance correct reaction time) /3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective fatigue</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective fatigue will be derived from the total score of the Piper Fatigue Scale. Scores range from 1 to 10. Higher scores are indicative of greater fatigue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of episodic memory</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for episodic memory will be derived by calculating the average score from 4 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy)/4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speed of episodic memory</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for speed of memory will be derived by calculating the average score from 2 separate standardised task outcomes (Zpicture recognition correct reaction time + Zword recognition correct reaction time)/2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of attention</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for accuracy of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time accuracy + ZZRapid visual information processing accuracy + ZZDigit Vigilance accuracy)/3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of executive function</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for executive function will be derived by calculating the average score from 5 separate standardised task outcomes (Znumeric working memory accuracy + ZZserial 3 subtractions accuracy + ZZserial 7 subtractions accuracy + ZStroop accuracy - ZPeg and Ball errors)/5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speed of executive function</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for speed of executive function will be derived by calculating the average score from 3 separate standardised task outcomes (Znumeric working memory correct reaction time + Zstroop correct reaction time + ZPeg and Ball overall reaction time)/3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computerised location learning task</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score is calculated utilising the total displacement over the 5 learning trials to create a total learning index score. Scores range from 0 to 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective overall mood disturbance</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective mood disturbance is derived from the overall score of the Profile of Mood States questionnaire. Higher scores indicate a greater degree of overall mood disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective sleep quality is derived from the overall score of the Sleep Condition Indicator. Total scores ranged from 0 to 32. Higher scores are indicative of greater subjective sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective stress</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective stress is derived from the overall score of the Perceived Stress Scale. Higher scores are indicative of greater subjective stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health outcomes</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective health outcomes are derived from the SF-12. Scores range from 0 to 100. Higher scores are indicative of better self-reported health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective alertness</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of alertness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective mental fatigue</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of mental fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global accuracy</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for global accuracy will be derived by calculating the average score from 13 separate standardised outcomes (ZChoice reaction time accuracy + ZZRapid visual information processing accuracy + ZNumeric working memory accuracy + ZZDigit Vigilance accuracy + ZStroop accuracy - ZPeg and Ball Errors + ZZSerial 3 subtractions accuracy + ZZSSerial 7 subtractions accuracy + ZPicture recognition accuracy + ZWord recognition accuracy + ZImmediate word recall accuracy + ZDelayed word recall accuracy + ZZComputerised location learning accuracy)/13</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global speed</measure>
    <time_frame>16 weeks</time_frame>
    <description>An overall score for global speed will be derived by calculating the average score from 8 separate standardised outcomes (ZChoice reaction time correct reaction time + ZNumeric working memory correct reaction time + ZDigit vigilance correct reaction time + ZZPeg and Ball overall reaction time + ZStroop correct reaction time + ZPicture recognition correct reaction time + ZWord recognition correct reaction time + ZRapid visual information correct reaction time) /8</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Cognitive Function and Mood</condition>
  <condition>Non-anaemic Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Iron and Vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>28mg iron bis-glycinate chelate and 240mg vitamin C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>28mg iron bis-glycinate chelate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Iron Bis-Glycinate Chelate and Vitamin C</intervention_name>
    <description>28 mg iron 240 mg vitamin C</description>
    <arm_group_label>Iron and Vitamin C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Iron Bis-Glycinate Chelate</intervention_name>
    <description>28 mg iron</description>
    <arm_group_label>Iron</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matched placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Aged 18-49 (inclusive)&#xD;
&#xD;
          -  Have a BMI of between 18.5-40&#xD;
&#xD;
          -  Have an English bank account (required for payment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged under 18 or above 49 years&#xD;
&#xD;
          -  BMI lower than 18.5 or higher than 40&#xD;
&#xD;
          -  Pre-existing medical condition/illness with some exceptions - please check with&#xD;
             researcher&#xD;
&#xD;
          -  Blood disorders (including anaemia) or any known active infections&#xD;
&#xD;
          -  Current or past breast cancer diagnosis and/or mastectomy&#xD;
&#xD;
          -  Smoking or use of any nicotine replacement products e.g. vaping, gum, patches&#xD;
&#xD;
          -  Pregnant, trying to get pregnant or breast feeding&#xD;
&#xD;
          -  Currently taking any prescription medication with some exceptions - please check with&#xD;
             researcher&#xD;
&#xD;
          -  Food allergies/sensitivities relevant to the study&#xD;
&#xD;
          -  Regular use of dietary/herbal supplements within the last month (defined as more than&#xD;
             3 consecutive days or 4 days in total)&#xD;
&#xD;
          -  Use of iron supplements within the past 4 months&#xD;
&#xD;
          -  Have donated more than 300ml of blood in the past 3 months&#xD;
&#xD;
          -  Have haemoglobin levels below 120g/L&#xD;
&#xD;
          -  History of significant head trauma or suffer from frequent migraines that require&#xD;
             medication (more than or equal to one per month)&#xD;
&#xD;
          -  Learning difficulties, dyslexia, or colour blindness&#xD;
&#xD;
          -  Visual impairment that cannot be corrected with glasses or contact lenses&#xD;
&#xD;
          -  Currently taking part in any other clinical or nutritional intervention studies or&#xD;
             have in the past 4 weeks&#xD;
&#xD;
          -  Any health condition that would prevent fulfillment of the study requirements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants must be female as assigned at birth</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northumbria University</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE1 8ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognition</keyword>
  <keyword>Mood</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Well-being</keyword>
  <keyword>Women's health</keyword>
  <keyword>Iron supplementation</keyword>
  <keyword>Vitamin C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</mesh_term>
    <mesh_term>Chelating Agents</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469010
org study id: 9BN1
nct id: NCT04469010
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Iron deficiency is the most prevalent nutritional deficiency worldwide with one in four
      estimated to be affected by iron deficiency anaemia. Women of reproductive age are at
      greatest risk for iron deficiency and anaemia due to iron losses during menstruation and
      childbirth as well as the increased need for iron throughout pregnancy. However, iron
      deficiency without anaemia is at least twice as common as iron deficiency anaemia with
      females aged 11-49 at the biggest risk of all. Despite this, it is commonly left undiagnosed.
      Those who are iron deficient non-anaemic can still suffer from the same common consequences
      of iron deficiency anaemia; these include unexplained fatigue, mood changes and decreased
      cognitive performance. However, randomised controlled trials (RCTs) assessing the effect of
      iron supplementation upon cognitive performance, mood, fatigue and well-being in non-anaemic
      iron deficient women of reproductive age are limited. There is also a lack of well-defined
      diagnostic criteria for non-anaemic iron deficiency, which makes comparisons across RCTs
      difficult. However, there is evidence to suggest that a haemoglobin cut off of ≥120 g/L and
      serum ferritin ≤ 20 µg/L provides an accurate indication of non-anaemic iron deficiency in
      women of reproductive age; this is inclusive of the ability to recognise iron-associated
      deficits in psychological and physiological functioning. Additionally, previous RCTs could be
      improved by utilising a lower dose of iron in a bis-glycinate chelate form, which is
      evidenced to have superior bioavailability, tolerability and subsequent efficacy compared to
      ferrous formulations. Iron bis-glycinate absorption is also negatively associated to serum
      ferritin levels, which is suggestive of a non-anaemic iron deficient population benefitting
      most from it's administration. The current study aims to build upon previous iron RCTs in
      populations of non-anaemic iron deficient and iron sufficient women of reproductive age by
      investigating the effects of 16-weeks supplementation with either iron bis-glycinate chelate
      alone, iron bis-glycinate plus vitamin C (as ascorbic acid) or matched placebo upon cognitive
      performance, subjective mood, fatigue, health and well-being.
Each participant will be required to attend the laboratory on four occasions. The first is
      comprised of a screening/training visit, which will take place in the afternoon for
      approximately 2.5 hours. This will also be between days 21-28/ the week before onset of their
      menstrual cycle. If they do not have menstrual bleeds then this appointment can be any
      afternoon. This will comprise: briefing of requirements of the study; obtaining of informed
      consent; confirmation of eligibility to take part, including collection of demographic data
      and health screening, and training on the cognitive and mood measures. The training session
      will follow standard operating procedures to decrease the chance of learning effects during
      main trials. Extra training will be given where necessary.

      Participants will be required to complete questionnaires based upon food frequency, caffeine
      consumption and to estimate the number of hours of exercise completed on a weekly basis. A
      menstrual cycle questionnaire will also be completed to estimate menstrual blood loss and so
      that participants attend their testing visit during days 7-14 of their cycle. If participants
      do not have a menstrual cycle due to contraceptive methods, then appointments will be
      approximately two weeks apart. A finger-prick and venous blood sample will be collected from
      participants, which will be analysed for iron status. Those whose haemoglobin levels are
      <120g/L will be advised to seek advice from their GP. Participants who fell into the iron
      status category of iron sufficient (haemoglobin ≥120 g/L and serum ferritin > 20 µg/L) or
      non-anaemic iron deficient (haemoglobin ≥120 g/L and serum ferritin ≤ 20 µg/L) will be
      informed of their eligibility for the intervention study by email or phone between the
      initial visit and their next.

      For the testing visit, participants will be asked to fast for 12 hours prior to the visit,
      avoiding intake of all food and drink with the exception of water. They will also be asked to
      avoid alcohol and refrain from intake of 'over the counter' medication for 24 hours.
      Participants will arrive at the laboratory at a designated time in the morning. The following
      procedures will take place prior to cognitive and mood testing:

        -  Review of continued conformity to eligibility criteria

        -  Adverse event and concomitant medication assessment

        -  Ensure that participant is in good health Participants will then complete the baseline
           cognitive and mood assessments. Following this, participants are informed of their iron
           status and will be briefed regarding the requirements of the intervention study.
           Following this, informed consent will be obtained prior to randomising participants to
           one of three treatments and providing them with a treatment diary to log treatment
           consumption and any adverse events experienced.

      Participants will return to the laboratory after 8 weeks to exchange treatment bottles and
      diaries in order to check compliance.

      Participants will finally return to the laboratory after a further 8 weeks (16 weeks total).
      The same procedures will take place prior to cognitive and mood testing as completed at the
      baseline testing visit, with the addition of finger prick and venous blood sample and weight
      measurement. Participants will then complete the same cognitive and mood assessments as
      completed during the baseline testing visit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will receive either iron and vitamin C, iron alone or placebo for a period of 16 weeks to consume daily
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Speed of attention
time frame: 16 weeks
description: An overall score for Speed of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time correct reaction time + ZRapid visual information processing correct reaction time + ZDigit vigilance correct reaction time) /3
measure: Subjective fatigue
time frame: 16 weeks
description: Subjective fatigue will be derived from the total score of the Piper Fatigue Scale. Scores range from 1 to 10. Higher scores are indicative of greater fatigue.
measure: Accuracy of episodic memory
time frame: 16 weeks
description: An overall score for episodic memory will be derived by calculating the average score from 4 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy)/4
measure: Speed of episodic memory
time frame: 16 weeks
description: An overall score for speed of memory will be derived by calculating the average score from 2 separate standardised task outcomes (Zpicture recognition correct reaction time + Zword recognition correct reaction time)/2
measure: Accuracy of attention
time frame: 16 weeks
description: An overall score for accuracy of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time accuracy + ZZRapid visual information processing accuracy + ZZDigit Vigilance accuracy)/3
measure: Accuracy of executive function
time frame: 16 weeks
description: An overall score for executive function will be derived by calculating the average score from 5 separate standardised task outcomes (Znumeric working memory accuracy + ZZserial 3 subtractions accuracy + ZZserial 7 subtractions accuracy + ZStroop accuracy - ZPeg and Ball errors)/5
measure: Speed of executive function
time frame: 16 weeks
description: An overall score for speed of executive function will be derived by calculating the average score from 3 separate standardised task outcomes (Znumeric working memory correct reaction time + Zstroop correct reaction time + ZPeg and Ball overall reaction time)/3
measure: Computerised location learning task
time frame: 16 weeks
description: An overall score is calculated utilising the total displacement over the 5 learning trials to create a total learning index score. Scores range from 0 to 1.
measure: Subjective overall mood disturbance
time frame: 16 weeks
description: Subjective mood disturbance is derived from the overall score of the Profile of Mood States questionnaire. Higher scores indicate a greater degree of overall mood disturbance.
measure: Subjective sleep quality
time frame: 16 weeks
description: Subjective sleep quality is derived from the overall score of the Sleep Condition Indicator. Total scores ranged from 0 to 32. Higher scores are indicative of greater subjective sleep quality.
measure: Subjective stress
time frame: 16 weeks
description: Subjective stress is derived from the overall score of the Perceived Stress Scale. Higher scores are indicative of greater subjective stress
measure: Health outcomes
time frame: 16 weeks
description: Subjective health outcomes are derived from the SF-12. Scores range from 0 to 100. Higher scores are indicative of better self-reported health.
measure: Subjective alertness
time frame: 16 weeks
description: Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of alertness.
measure: Subjective mental fatigue
time frame: 16 weeks
description: Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of mental fatigue.
measure: Global accuracy
time frame: 16 weeks
description: An overall score for global accuracy will be derived by calculating the average score from 13 separate standardised outcomes (ZChoice reaction time accuracy + ZZRapid visual information processing accuracy + ZNumeric working memory accuracy + ZZDigit Vigilance accuracy + ZStroop accuracy - ZPeg and Ball Errors + ZZSerial 3 subtractions accuracy + ZZSSerial 7 subtractions accuracy + ZPicture recognition accuracy + ZWord recognition accuracy + ZImmediate word recall accuracy + ZDelayed word recall accuracy + ZZComputerised location learning accuracy)/13
measure: Global speed
time frame: 16 weeks
description: An overall score for global speed will be derived by calculating the average score from 8 separate standardised outcomes (ZChoice reaction time correct reaction time + ZNumeric working memory correct reaction time + ZDigit vigilance correct reaction time + ZZPeg and Ball overall reaction time + ZStroop correct reaction time + ZPicture recognition correct reaction time + ZWord recognition correct reaction time + ZRapid visual information correct reaction time) /8
arm group label: Iron and Vitamin C
arm group type: Experimental
description: 28mg iron bis-glycinate chelate and 240mg vitamin C
arm group label: Iron
arm group type: Active Comparator
description: 28mg iron bis-glycinate chelate
arm group label: Placebo
arm group type: Placebo Comparator
description: Matched placebo tablets
intervention type: Dietary Supplement
intervention name: Iron Bis-Glycinate Chelate and Vitamin C
description: 28 mg iron 240 mg vitamin C
arm group label: Iron and Vitamin C
intervention type: Dietary Supplement
intervention name: Iron Bis-Glycinate Chelate
description: 28 mg iron
arm group label: Iron
intervention type: Dietary Supplement
intervention name: Placebo
description: Matched placebo
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: Participants must be female as assigned at birth
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Iron Deficiencies
mesh term: Fatigue
mesh term: Iron
mesh term: Chelating Agents