<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/NCT03256123</url>
  </required_header>
  <id_info>
    <org_study_id>PD219/16</org_study_id>
    <nct_id>NCT03256123</nct_id>
  </id_info>
  <brief_title>The Effects of Biscuits Containing Red Palm Oil on School Children With Vitamin A Deficiency in West and East Malaysia</brief_title>
  <official_title>The Effect of Biscuits Containing Red Palm Oil on School Children With Vitamin A Deficiency in West and East Malaysia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malaysia Palm Oil Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Malaysia Palm Oil Board</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children&#xD;
      aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural&#xD;
      areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas&#xD;
      (3.8%). Besides, prevalence of iron deficiency due to low ferritin concentrations is 4.4% and&#xD;
      anaemia based on low haemoglobin concentrations is 6.6%. It is proposed that a red palm oil&#xD;
      intervention programme to be conducted in alliance with RMT in Malaysia to enhance the&#xD;
      Vitamin A status of school children in underprivileged community in Malaysia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deficiency of vitamin A or retinol is a public health problem and listed as the most&#xD;
      widespread nutritional deficiency worldwide (Sommer, 1995). According to the World Health&#xD;
      Organization (WHO), about 190 million preschool children in underdeveloped countries&#xD;
      especially in the region of Africa and South-East Asia are vitamin A deficient (2011, 2011).&#xD;
      Infants and children have higher vitamin A requirements to promote rapid growth and better&#xD;
      immunity to combat infections. Vitamin A deficiency in children causes visual impairment and&#xD;
      blindness, risk of infection, stunting, anemia, respiratory diseases and mortality due to&#xD;
      common childhood infections such as diarrhea and measles. On the basis on Cochrane&#xD;
      meta-analysis on 194,795 children, vitamin A supplementation could reduce childhood mortality&#xD;
      by 23% and incidences of illnesses (Imdad et al., 2010).&#xD;
&#xD;
      According to WHO, an estimated 2.8 million preschool-age children are at risk of nutritional&#xD;
      blindness or active xerophthalmia due to Vitamin A deficiency in low-income countries&#xD;
      (Organization, 2010). Sadly, approximately 250 000 to 500 000 children suffering from vitamin&#xD;
      A deficiency become blind yearly, and half of the number die within a year of losing their&#xD;
      vision (Organization, 2010). The different eye signs of vitamin A deficiency (VAD) in&#xD;
      children as graded by the WHO are night blindness, conjunctival xerosis, Bitot's spots,&#xD;
      corneal xerosis, corneal ulcer/keratomalacia and corneal scarring (Sommer, 1995). Severe&#xD;
      vitamin A deficiency distresses ocular tissue by reducing regeneration of visual pigment upon&#xD;
      exposure to bright light or lasting damage on the epithelium of the cornea and conjunctiva.&#xD;
      Classical ocular manifestation due to vitamin A deficiency may lead to less serious Bitot's&#xD;
      spots and night blindness, or severe xerophthalmia and keratomalacia leading to blindness&#xD;
      (Scrimshaw, 2000). Ocular manifestation of vitamin A deficiency still exists in&#xD;
      underprivileged communities in Malaysia (Ngah et al., 2002). Vitamin A deficiency is&#xD;
      prevalent in pre-school and primary school children of aborigines (&quot;Orang Asli&quot;) and those&#xD;
      from rubber estates. 82.2% of Orang Asli children had ocular manifestations of vitamin A&#xD;
      deficiency ranging from history of night blindness to corneal scars (Ngah et al., 2002).&#xD;
      Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children&#xD;
      aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural&#xD;
      areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas&#xD;
      (3.8%) (Poh et al., 2013).&#xD;
&#xD;
      There is significant association between iron deficiency and vitamin A deficiency represented&#xD;
      by low serum retinol (Al-Mekhlafi et al., 2013). According to WHO, iron deficiency is the&#xD;
      commonest and widespread nutritional deficiency in the world. Over 30% of the world's&#xD;
      population are known to be anaemic due to iron deficiency, poor diet, or exposed to&#xD;
      infectious diseases. Malaria, HIV/AIDS, hookworm infestation, schistosomiasis, and other&#xD;
      infections such as tuberculosis are particularly important factors contributing to the high&#xD;
      prevalence of anaemia in some areas. Iron deficiency may lead to impaired health, development&#xD;
      and learning in children. Based on Malaysian SEANUTS survey, the overall prevalence of iron&#xD;
      deficiency due to low ferritin concentrations is 4.4% and anaemia based on low haemoglobin&#xD;
      concentrations is 6.6% (Poh et al., 2013). The occurrence of anaemia and iron deficiency&#xD;
      among Orang Asli children is relatively high. The Orang Asli children aged 2-15 years old,&#xD;
      living in eight villages in Selangor showed high episodes of anaemia 41.5% and 36.5% had iron&#xD;
      deficiency anaemia. In another recent study, nearly half (48.5%) of the Orang Asli children&#xD;
      from 18 villages in Pahang were found to be anaemic and the prevalence of iron deficiency was&#xD;
      34% (Al-Mekhlafi et al., 2013).&#xD;
&#xD;
      In Malaysia, the school-feeding program is called &quot;Rancangan Makanan Tambahan (RMT)&quot; which&#xD;
      literally means additional food plan. The RMT program is provided only to primary school&#xD;
      children (aged 6 - 12 years) from poor families. It is not meant to replace food served at&#xD;
      home, but to provide extra nourishment for children from poor families. The RMT program is&#xD;
      managed by the School Division of the Ministry of Education, Malaysia. Food is served during&#xD;
      recess time (10.30 a.m. for morning session, and 3.30pm for afternoon session) and provides&#xD;
      1/4 to 1/3 of daily requirements. It is proposed that a red palm oil intervention programme&#xD;
      to be conducted in alliance with RMT in Malaysia to enhance the Vitamin A status of school&#xD;
      children in underprivileged community in Malaysia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>In this study, the subjects will be randomly assigned to two groups: a group receiving biscuits with red palm oil and a control group receiving biscuits with palm shortening with corresponding fatty acids.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retinol level</measure>
    <time_frame>During screening, after 6 months of dietary intervention period and post 200 days after the intervention.</time_frame>
    <description>Vitamin A deficiency is defined as concentration of serum retinol &lt;0.70 µmol/L and suspected vitamin A deficiency is defined as concentration of serum retinol 0.70 - 1.04 µmol/L.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum beta carotene, alpha carotene, vitamin E levels</measure>
    <time_frame>During screening, after 6 months of dietary intervention period and post 200 days after the intervention.</time_frame>
    <description>Serum beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinol binding protein levels</measure>
    <time_frame>During screening, after 6 months of dietary intervention period and post 200 days after the intervention.</time_frame>
    <description>Retinol is transported in a 1-to-1 complex with retinol-binding protein. The cutoff od equimolar RBP is able to predict vitamin A deficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin and ferritin level</measure>
    <time_frame>During screening, after 6 months of dietary intervention period and post 200 days after the intervention.</time_frame>
    <description>vitamin A is essential for normal haematopoiesis. The occurrence of anaemia is indicated by haemoglobin concentration lower than 115 g/L. The occurrence of iron deficiency is indicated by the serum ferritin concentration lower than 15 μg/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular signs</measure>
    <time_frame>During screening, after 6 months of dietary intervention period and post 200 days after the intervention.</time_frame>
    <description>Eyes examined at optimal light for conjuctival xerosis, Bitot's spots, corneal xerosis, and corneal ulceration or keratomalacia. The eye assessments include visual acuity assessment via a Snellen chart, examination with a portable slit lamp for signs of xerophthalmia, fundus photography with portable non mydriatic camera and questionnaire on night blindness symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory/infection status</measure>
    <time_frame>During screening, after 6 months of dietary intervention period and post 200 days after the intervention.</time_frame>
    <description>high sensitivity C-reactive protein (hsCRP), fibrinogen, haematology tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut Microbiota</measure>
    <time_frame>at the baseline, 3 months after intervention, after 6-months intervention.</time_frame>
    <description>As malnutrition is generally associated with the changes in gut microbiota [14], it is important to study the effects of red palm oil-fortified biscuit supplementation to gut microbiota of VAD children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soil-transmitted helminths</measure>
    <time_frame>at the baseline, 3 months after intervention, after 6-months intervention.</time_frame>
    <description>Malnutrition can weaken immune responses and increase the susceptibility to bacterial and parasitic infections. Therefore, the supplementation of vitamin A to VAD children has the potential to boost their immunity against bacterial and parasitic infections.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Vitamin A Deficiency in Children</condition>
  <arm_group>
    <arm_group_label>red palm shortening group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group receiving the supplementation of red palm shortening biscuits. The subjects are expected to receive 630 µg RE of vitamin A/day by consuming the biscuits four days a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>palm shortening group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A group receiving supplementation of palm shortening biscuits with corresponding fatty acids as red palm shortening group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>red palm shortening group</intervention_name>
    <description>Biscuits made of red palm shortening will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The biscuits for each subject will contain ~200 kcal with 10 g of red palm shortening/day (630 µg RE/day). This biscuit would be given four days a week on schooling days for a duration of 6 months. On average in a week, subject is expected to receive 630 µg RE of vitamin A/day. This would fulfill ~70% of the RNI of vitamin A for children aged 7-11 years old.</description>
    <arm_group_label>red palm shortening group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>palm shortening group</intervention_name>
    <description>Biscuits made of palm shortening (control group) will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The palm shortening biscuits contain corresponding fatty acids as red palm shortening group.</description>
    <arm_group_label>palm shortening group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 7-11 years old&#xD;
&#xD;
          -  Vitamin A deficient children defined as concentration of serum retinol &lt;0.70 µmol/L&#xD;
             and suspected vitamin A deficiency defined as concentration of serum retinol 0.70 -&#xD;
             1.04 µmol/L.&#xD;
&#xD;
          -  Not physically handicapped&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Children with malaria, oedema including severe acute malnutrition, nephritic&#xD;
             syndrome, or gastrointestinal disorders&#xD;
&#xD;
          -  Children allergic to wheat- and/or gluten-containing foods&#xD;
&#xD;
          -  Children who are studying Primary Six&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KIM TIU TENG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysia Palm Oil Board</affiliation>
  </overall_official>
  <overall_official>
    <last_name>RADHIKA LOGANATHAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysia Palm Oil Board</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PEI YEE TAN</last_name>
    <phone>+6012-9363227</phone>
    <email>tpyee_april17@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>SYAHIRAH NADIAH BINTI MOHD JOHARI</last_name>
    <phone>+6011-32357476</phone>
    <email>syahirahnadiahmj@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Malaysian Palm Oil Board</name>
      <address>
        <city>Kajang</city>
        <state>Selangor</state>
        <zip>43000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PEI YEE TAN</last_name>
      <phone>+6012-9363227</phone>
      <email>tpyee_april17@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>SYAHIRAH NADIAH MOHD JOHARI</last_name>
      <phone>+6011-32357476</phone>
      <email>syahirahnadiahmj@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kim Tiu Teng</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Radhika Loganathan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ai Lian Yvonne Lim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Soo Ching Lee</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romano Ngui</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kanga Rani Selvaduray</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <results_reference>
    <citation>Al-Mekhlafi HM, Al-Zabedi EM, Al-Maktari MT, Atroosh WM, Al-Delaimy AK, Moktar N, Sallam AA, Abdullah WA, Jani R, Surin J. Effects of vitamin A supplementation on iron status indices and iron deficiency anaemia: a randomized controlled trial. Nutrients. 2013 Dec 31;6(1):190-206. doi: 10.3390/nu6010190.</citation>
    <PMID>24384995</PMID>
  </results_reference>
  <results_reference>
    <citation>van Stuijvenberg ME, Faber M, Dhansay MA, Lombard CJ, Vorster N, Benade AJ. Red palm oil as a source of beta-carotene in a school biscuit used to address vitamin A deficiency in primary school children. Int J Food Sci Nutr. 2000;51 Suppl:S43-50. doi: 10.1080/096374800750049567.</citation>
    <PMID>11271856</PMID>
  </results_reference>
  <results_reference>
    <citation>Zeba AN, Martin Prevel Y, Some IT, Delisle HF. The positive impact of red palm oil in school meals on vitamin A status: study in Burkina Faso. Nutr J. 2006 Jul 17;5:17. doi: 10.1186/1475-2891-5-17.</citation>
    <PMID>16846498</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin A Deficiency</keyword>
  <keyword>Iron Deficiency</keyword>
  <keyword>Parasite</keyword>
  <keyword>Gut Microbiota</keyword>
  <keyword>Red palm oil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Night Blindness</mesh_term>
    <mesh_term>Vitamin A Deficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03256123
org study id: PD219/16
nct id: NCT03256123
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children
      aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural
      areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas
      (3.8%). Besides, prevalence of iron deficiency due to low ferritin concentrations is 4.4% and
      anaemia based on low haemoglobin concentrations is 6.6%. It is proposed that a red palm oil
      intervention programme to be conducted in alliance with RMT in Malaysia to enhance the
      Vitamin A status of school children in underprivileged community in Malaysia.
Deficiency of vitamin A or retinol is a public health problem and listed as the most
      widespread nutritional deficiency worldwide (Sommer, 1995). According to the World Health
      Organization (WHO), about 190 million preschool children in underdeveloped countries
      especially in the region of Africa and South-East Asia are vitamin A deficient (2011, 2011).
      Infants and children have higher vitamin A requirements to promote rapid growth and better
      immunity to combat infections. Vitamin A deficiency in children causes visual impairment and
      blindness, risk of infection, stunting, anemia, respiratory diseases and mortality due to
      common childhood infections such as diarrhea and measles. On the basis on Cochrane
      meta-analysis on 194,795 children, vitamin A supplementation could reduce childhood mortality
      by 23% and incidences of illnesses (Imdad et al., 2010).

      According to WHO, an estimated 2.8 million preschool-age children are at risk of nutritional
      blindness or active xerophthalmia due to Vitamin A deficiency in low-income countries
      (Organization, 2010). Sadly, approximately 250 000 to 500 000 children suffering from vitamin
      A deficiency become blind yearly, and half of the number die within a year of losing their
      vision (Organization, 2010). The different eye signs of vitamin A deficiency (VAD) in
      children as graded by the WHO are night blindness, conjunctival xerosis, Bitot's spots,
      corneal xerosis, corneal ulcer/keratomalacia and corneal scarring (Sommer, 1995). Severe
      vitamin A deficiency distresses ocular tissue by reducing regeneration of visual pigment upon
      exposure to bright light or lasting damage on the epithelium of the cornea and conjunctiva.
      Classical ocular manifestation due to vitamin A deficiency may lead to less serious Bitot's
      spots and night blindness, or severe xerophthalmia and keratomalacia leading to blindness
      (Scrimshaw, 2000). Ocular manifestation of vitamin A deficiency still exists in
      underprivileged communities in Malaysia (Ngah et al., 2002). Vitamin A deficiency is
      prevalent in pre-school and primary school children of aborigines ("Orang Asli") and those
      from rubber estates. 82.2% of Orang Asli children had ocular manifestations of vitamin A
      deficiency ranging from history of night blindness to corneal scars (Ngah et al., 2002).
      Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children
      aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural
      areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas
      (3.8%) (Poh et al., 2013).

      There is significant association between iron deficiency and vitamin A deficiency represented
      by low serum retinol (Al-Mekhlafi et al., 2013). According to WHO, iron deficiency is the
      commonest and widespread nutritional deficiency in the world. Over 30% of the world's
      population are known to be anaemic due to iron deficiency, poor diet, or exposed to
      infectious diseases. Malaria, HIV/AIDS, hookworm infestation, schistosomiasis, and other
      infections such as tuberculosis are particularly important factors contributing to the high
      prevalence of anaemia in some areas. Iron deficiency may lead to impaired health, development
      and learning in children. Based on Malaysian SEANUTS survey, the overall prevalence of iron
      deficiency due to low ferritin concentrations is 4.4% and anaemia based on low haemoglobin
      concentrations is 6.6% (Poh et al., 2013). The occurrence of anaemia and iron deficiency
      among Orang Asli children is relatively high. The Orang Asli children aged 2-15 years old,
      living in eight villages in Selangor showed high episodes of anaemia 41.5% and 36.5% had iron
      deficiency anaemia. In another recent study, nearly half (48.5%) of the Orang Asli children
      from 18 villages in Pahang were found to be anaemic and the prevalence of iron deficiency was
      34% (Al-Mekhlafi et al., 2013).

      In Malaysia, the school-feeding program is called "Rancangan Makanan Tambahan (RMT)" which
      literally means additional food plan. The RMT program is provided only to primary school
      children (aged 6 - 12 years) from poor families. It is not meant to replace food served at
      home, but to provide extra nourishment for children from poor families. The RMT program is
      managed by the School Division of the Ministry of Education, Malaysia. Food is served during
      recess time (10.30 a.m. for morning session, and 3.30pm for afternoon session) and provides
      1/4 to 1/3 of daily requirements. It is proposed that a red palm oil intervention programme
      to be conducted in alliance with RMT in Malaysia to enhance the Vitamin A status of school
      children in underprivileged community in Malaysia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, the subjects will be randomly assigned to two groups: a group receiving biscuits with red palm oil and a control group receiving biscuits with palm shortening with corresponding fatty acids.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Retinol level
time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
description: Vitamin A deficiency is defined as concentration of serum retinol <0.70 µmol/L and suspected vitamin A deficiency is defined as concentration of serum retinol 0.70 - 1.04 µmol/L.
measure: Serum beta carotene, alpha carotene, vitamin E levels
time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
description: Serum beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids
measure: Retinol binding protein levels
time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
description: Retinol is transported in a 1-to-1 complex with retinol-binding protein. The cutoff od equimolar RBP is able to predict vitamin A deficiency
measure: Hemoglobin and ferritin level
time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
description: vitamin A is essential for normal haematopoiesis. The occurrence of anaemia is indicated by haemoglobin concentration lower than 115 g/L. The occurrence of iron deficiency is indicated by the serum ferritin concentration lower than 15 μg/L.
measure: Ocular signs
time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
description: Eyes examined at optimal light for conjuctival xerosis, Bitot's spots, corneal xerosis, and corneal ulceration or keratomalacia. The eye assessments include visual acuity assessment via a Snellen chart, examination with a portable slit lamp for signs of xerophthalmia, fundus photography with portable non mydriatic camera and questionnaire on night blindness symptoms.
measure: Inflammatory/infection status
time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
description: high sensitivity C-reactive protein (hsCRP), fibrinogen, haematology tests
measure: Gut Microbiota
time frame: at the baseline, 3 months after intervention, after 6-months intervention.
description: As malnutrition is generally associated with the changes in gut microbiota [14], it is important to study the effects of red palm oil-fortified biscuit supplementation to gut microbiota of VAD children.
measure: Soil-transmitted helminths
time frame: at the baseline, 3 months after intervention, after 6-months intervention.
description: Malnutrition can weaken immune responses and increase the susceptibility to bacterial and parasitic infections. Therefore, the supplementation of vitamin A to VAD children has the potential to boost their immunity against bacterial and parasitic infections.
arm group label: red palm shortening group
arm group type: Experimental
description: A group receiving the supplementation of red palm shortening biscuits. The subjects are expected to receive 630 µg RE of vitamin A/day by consuming the biscuits four days a week.
arm group label: palm shortening group
arm group type: Placebo Comparator
description: A group receiving supplementation of palm shortening biscuits with corresponding fatty acids as red palm shortening group.
intervention type: Dietary Supplement
intervention name: red palm shortening group
description: Biscuits made of red palm shortening will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The biscuits for each subject will contain ~200 kcal with 10 g of red palm shortening/day (630 µg RE/day). This biscuit would be given four days a week on schooling days for a duration of 6 months. On average in a week, subject is expected to receive 630 µg RE of vitamin A/day. This would fulfill ~70% of the RNI of vitamin A for children aged 7-11 years old.
arm group label: red palm shortening group
intervention type: Dietary Supplement
intervention name: palm shortening group
description: Biscuits made of palm shortening (control group) will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The palm shortening biscuits contain corresponding fatty acids as red palm shortening group.
arm group label: palm shortening group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: KIM TIU TENG
role: Principal Investigator
affiliation: Malaysia Palm Oil Board
last name: RADHIKA LOGANATHAN
role: Principal Investigator
affiliation: Malaysia Palm Oil Board
last name: PEI YEE TAN
phone: +6012-9363227
email: tpyee_april17@hotmail.com
last name: SYAHIRAH NADIAH BINTI MOHD JOHARI
phone: +6011-32357476
email: syahirahnadiahmj@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
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country: Malaysia
citation: Al-Mekhlafi HM, Al-Zabedi EM, Al-Maktari MT, Atroosh WM, Al-Delaimy AK, Moktar N, Sallam AA, Abdullah WA, Jani R, Surin J. Effects of vitamin A supplementation on iron status indices and iron deficiency anaemia: a randomized controlled trial. Nutrients. 2013 Dec 31;6(1):190-206. doi: 10.3390/nu6010190.
PMID: 24384995
citation: van Stuijvenberg ME, Faber M, Dhansay MA, Lombard CJ, Vorster N, Benade AJ. Red palm oil as a source of beta-carotene in a school biscuit used to address vitamin A deficiency in primary school children. Int J Food Sci Nutr. 2000;51 Suppl:S43-50. doi: 10.1080/096374800750049567.
PMID: 11271856
citation: Zeba AN, Martin Prevel Y, Some IT, Delisle HF. The positive impact of red palm oil in school meals on vitamin A status: study in Burkina Faso. Nutr J. 2006 Jul 17;5:17. doi: 10.1186/1475-2891-5-17.
PMID: 16846498
responsible party type: Sponsor
mesh term: Night Blindness
mesh term: Vitamin A Deficiency
sharing ipd: No