xml: <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/NCT05981534</url>
    </required_header>
    <id_info>
      <org_study_id>2022.252</org_study_id>
      <nct_id>NCT05981534</nct_id>
    </id_info>
    <brief_title>the Effectiveness of Vitamin D Supplementation on Sarcopenia in Patients With End-stage Knee Osteoarthritis</brief_title>
    <official_title>Double-blinded Randomized Controlled Trial Investigating the Effectiveness of Vitamin D Supplementation on Sarcopenia in Patients With End-stage Knee Osteoarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Osteoarthritis (OA) knee is one of the commonest chronic degenerative conditions. It causes&#xD;
        disability in elderlies due to pain and stiffness. The prevalence of radiologic knee&#xD;
        osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients who&#xD;
        are over 60 years of age. In 2021, there were over 26,000 patients on the Hospital Authority&#xD;
        (HA) waiting list for knee total knee replacement (TKR) and with only 4300 TKRs performed,&#xD;
        the nominal waiting time for TKR was almost 89 months.&#xD;
  &#xD;
        Ageing and inactivity leads to a progressive loss of muscle mass and strength until an&#xD;
        abnormally low level, termed as &quot;sarcopenia&quot; (4). Sarcopenic elderlies are more likely to&#xD;
        develop deterioration of functional outcomes and higher mortality resulting in socioeconomic&#xD;
        and healthcare burdens.&#xD;
  &#xD;
        Low vitamin D can adversely affect cartilage thickness and study suggested that low serum&#xD;
        vitamin D is associated with increased radiographic knee OA progression (12). A systematic&#xD;
        review concluded that vitamin D supplements can improve pain and function in patients with&#xD;
        knee OA.&#xD;
  &#xD;
        Vitamin D has long been recognized for its effect on musculoskeletal health and increasing&#xD;
        attention has been focused for its effect on muscle function. Vitamin D have a direct effect&#xD;
        on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and&#xD;
        sufficient levels of vitamin D in patients have been found to correlate with an increase in&#xD;
        the size, number, and strength of muscle fibres. Vitamin D also seems to exert beneﬁcial&#xD;
        eﬀects by its interplay with myokines such as myostatin and irisin. It has been shown that&#xD;
        elderly individuals with vitamin D deficiency are susceptible to sarcopenia and there are&#xD;
        biological, clinical, and epidemiological evidence supporting the association between vitamin&#xD;
        D and an increased risk of sarcopenia in older people (14). The study also showed that muscle&#xD;
        nuclear VDR was increased by 30% and augmented muscle fibre size by 10% in elderly females&#xD;
        (mean age of 78 years) taking vitamin D orally at a rate of 100 µg/day (4000 IU/day) for 4&#xD;
        months (14).&#xD;
  &#xD;
        This will be a double-blinded RCT investigating the effect of vitamin D supplements, in&#xD;
        addition to exercise, for sarcopenic patients with end-stage knee OA.The study will be a&#xD;
        follow-up study with assessment at baseline, 4- and 6-months post vitamin D intervention, 2&#xD;
        months, and 6 months post TKR.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        96 patients with end-stage knee OA scheduled for TKR will be recruited from the Li Ka Shing&#xD;
        Orthopaedic Specialist clinic at the Prince of Wales Hospital (PWH) Hong Kong.&#xD;
  &#xD;
        Oral and written consents will be obtained from individuals who agree to participate in the&#xD;
        study. The recruitment period will last for 12 months and the whole project period is 2 years&#xD;
        in total. Basic demographics, sarcopenia assessment and Outcome Measurement Questionnaires&#xD;
        will be carried out. The patients will be advised to avoid taking supplements and keep a&#xD;
        record of medication intake throughout the study period.&#xD;
  &#xD;
        We will use 4000 IU/day, for 6 months adapted from previous study (22). This will allow for a&#xD;
        full 4 months of vitamin D supplementation before both groups of patients undergoing a&#xD;
        standardized physiotherapy program for 4 weeks (8 sessions), and to allow for any potential&#xD;
        minor change of TKR date. The final assessments will be performed within 2 weeks, and TKR&#xD;
        within 4 weeks after the completion of the physiotherapy program. All study tablets including&#xD;
        the placebo will be manufactured according to Good Manufacturing Practice (GMP) guidelines&#xD;
        for quality assurance.&#xD;
  &#xD;
        Assessments including quadriceps muscle strength, handgrip strength, 6-meter timed walking&#xD;
        gait test, chair stand test, muscle mass using Dual Energy X-ray Absorptiometry and&#xD;
        questionnaires will be conducted.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quadriceps muscle strength assessment</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>Hand-held dynamometer microFET2 (Hoggan Scientific, Salt Lake City UT, USA) will be used to assess lower limb strength and power. Assessment of isometric muscle strength and power will be performed with the participants in a seated position to assess knee extensors and knee flexors. All tests will involve maximal voluntary isometric contractions. Both limbs will be assessed to record side-to-side difference. Two trials were recorded for each muscle group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Handgrip strength</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>The handgrip dynamometer will be used to test for the patients' handgrip strength. The handgrip dynamometer is an instrument measuring patients' maximum isometric strength of the hand and forearm muscles. The handle of the dynamometer will be adjusted as the finger is at 90 o whilst the dynamometer is being held. The measurement will be repeated three times and the average calculated for the dominant hand (Hand dominance will be determined by observing the patient's writing hand when signing the informed consent).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>The 10-meter timed walking test is a well-established test to assess gait speed. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6-meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (&lt;7.5 seconds is normal).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chair stand test</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>The chair stand test is a reliable test for assessment for low limb strength in patients. Patients will be asked to sit on a solid chair with arms on shoulders and feet with shoulder width apart. They will be instructed to do 1-2 repetitions to become familiar with the test, and perform as many reputations as they can in 30 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dual Energy X-ray Absorptiometry (DXA)</measure>
      <time_frame>Baseline, 2 months after TKA</time_frame>
      <description>The radiation for one session (20 minutes) for sarcopenia assessment is less than 25µSv, which is within the safe range. After every DXA scan, two copies will be printed that show the patients' body composition, bone mineral density, fat percentage, body mass index, and most importantly for this study, lean muscle mass.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>It is a questionnaire that measures a patient's pain, stiffness and physical function and can be summed up into a score out of 96. A high score indicates a more disabled participant .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knee Society Score (KSS)</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>Assesses a patient's pain and functionality based on a series of questions interviewed by a clinician. The validated questionnaire combines the objective physician-derived component with a subjective patient-derived component which evaluates pain, functionality, satisfaction, and fulfilment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short-Form 12 (SF-12)</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>12 questions to measure a patient's functional health and well-being from a patient's point of view. It is a reliable and validated measure that summarises the patients' physical and mental health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Physical Activity Questionnaire (IPAQ)</measure>
      <time_frame>Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA</time_frame>
      <description>Assesses and monitors a patient's physical activity and inactivity level. This instrument sums up a patient's activity level per week into three categories, Category 1 Inactivity, category 2 minimally active and category 3 HEPA active</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutritional intake questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>Evaluation of habitual dietary intake will be based on retrospective means of assessment for the past twelve months. A Food Frequency Questionnaire (FFQ) previously validated with data obtained in the Hong Kong Adult Dietary Survey in 1995 as described previously will be used(Appendix 7). Daily dietary intake of Vitamin D and calcium will be evaluated by the Food Processor Nutrition Analysis and Fitness software version 7.9 (Esha Research, Salem, USA), with incorporation of local food composition based on food composition table from China</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Vitamin D Deficiency</condition>
    <condition>Sarcopenia</condition>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will recieve vitamin D supplement for 16 weeks plus standardised 4 weeks prehab for TKR.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group will recieve placebo for 16 weeks plus standardised 4 weeks prehab for TKR.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vitamin D</intervention_name>
      <description>4000IU/day vitamin D supplement will be used for 16 weeks plus standardised 4 weeks prehabilitation for TKR.</description>
      <arm_group_label>Intervention group</arm_group_label>
      <other_name>standardised prehabilitation</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be used for 16 weeks plus standardised 4 weeks prehabilitation for TKR.</description>
      <arm_group_label>Control group</arm_group_label>
      <other_name>standardised prehabilitation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1)Male and female patients aged over 70 with end-stage knee OA (2) Patient has been&#xD;
               scheduled for TKR at Prince of Wales Hospital (3) Walk unaided for 6 metres (4) Able&#xD;
               to comply with the assessments and has given oral and written consent (5) Patients&#xD;
               with vitamin D insufficiency and deficiency at the baseline measurement (25(OH)D &lt;30&#xD;
               ng/mL)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Patients with connective tissue disorders or myositis condition (2) History of any&#xD;
               Hip &amp; Knee surgery (3) Patients with malnutrition assessed by Mini-Nutritional&#xD;
               assessment. (4) Patients with acute immobility (i.e., post hip fracture or post-acute&#xD;
               hospital admission) (5) Patient scheduled for TKR within 6 months (6) Patients already&#xD;
               taking vitamin D supplements (7) Patients with a known contraindication to vitamin D&#xD;
               treatment (such as allergy) (8) Patients who have renal impairment with glomerular&#xD;
               filtration rate (eGFR) &lt; 30 ml/minute&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>70 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Tim-Yun ONG</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese University of Hong Kong</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Michael.Ong@Cuhk.Edu.Hk</name>
        <address>
          <city>Hong Kong</city>
          <state>NEW Territories</state>
          <country>Hong Kong</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Prof. Tim-Yun Michael ONG</investigator_full_name>
      <investigator_title>Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Vitamin D</keyword>
    <keyword>Sarcopenia</keyword>
    <keyword>Muscle atrophy</keyword>
    <keyword>Knee Osteoarthritis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Sarcopenia</mesh_term>
      <mesh_term>Vitamin D Deficiency</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin D</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
      <ipd_access_criteria>Journal reviewer</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981534
  org study id: 2022.252
  nct id: NCT05981534
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Osteoarthritis (OA) knee is one of the commonest chronic degenerative conditions. It causes
        disability in elderlies due to pain and stiffness. The prevalence of radiologic knee
        osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients who
        are over 60 years of age. In 2021, there were over 26,000 patients on the Hospital Authority
        (HA) waiting list for knee total knee replacement (TKR) and with only 4300 TKRs performed,
        the nominal waiting time for TKR was almost 89 months.
  
        Ageing and inactivity leads to a progressive loss of muscle mass and strength until an
        abnormally low level, termed as "sarcopenia" (4). Sarcopenic elderlies are more likely to
        develop deterioration of functional outcomes and higher mortality resulting in socioeconomic
        and healthcare burdens.
  
        Low vitamin D can adversely affect cartilage thickness and study suggested that low serum
        vitamin D is associated with increased radiographic knee OA progression (12). A systematic
        review concluded that vitamin D supplements can improve pain and function in patients with
        knee OA.
  
        Vitamin D has long been recognized for its effect on musculoskeletal health and increasing
        attention has been focused for its effect on muscle function. Vitamin D have a direct effect
        on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and
        sufficient levels of vitamin D in patients have been found to correlate with an increase in
        the size, number, and strength of muscle fibres. Vitamin D also seems to exert beneﬁcial
        eﬀects by its interplay with myokines such as myostatin and irisin. It has been shown that
        elderly individuals with vitamin D deficiency are susceptible to sarcopenia and there are
        biological, clinical, and epidemiological evidence supporting the association between vitamin
        D and an increased risk of sarcopenia in older people (14). The study also showed that muscle
        nuclear VDR was increased by 30% and augmented muscle fibre size by 10% in elderly females
        (mean age of 78 years) taking vitamin D orally at a rate of 100 µg/day (4000 IU/day) for 4
        months (14).
  
        This will be a double-blinded RCT investigating the effect of vitamin D supplements, in
        addition to exercise, for sarcopenic patients with end-stage knee OA.The study will be a
        follow-up study with assessment at baseline, 4- and 6-months post vitamin D intervention, 2
        months, and 6 months post TKR.
  96 patients with end-stage knee OA scheduled for TKR will be recruited from the Li Ka Shing
        Orthopaedic Specialist clinic at the Prince of Wales Hospital (PWH) Hong Kong.
  
        Oral and written consents will be obtained from individuals who agree to participate in the
        study. The recruitment period will last for 12 months and the whole project period is 2 years
        in total. Basic demographics, sarcopenia assessment and Outcome Measurement Questionnaires
        will be carried out. The patients will be advised to avoid taking supplements and keep a
        record of medication intake throughout the study period.
  
        We will use 4000 IU/day, for 6 months adapted from previous study (22). This will allow for a
        full 4 months of vitamin D supplementation before both groups of patients undergoing a
        standardized physiotherapy program for 4 weeks (8 sessions), and to allow for any potential
        minor change of TKR date. The final assessments will be performed within 2 weeks, and TKR
        within 4 weeks after the completion of the physiotherapy program. All study tablets including
        the placebo will be manufactured according to Good Manufacturing Practice (GMP) guidelines
        for quality assurance.
  
        Assessments including quadriceps muscle strength, handgrip strength, 6-meter timed walking
        gait test, chair stand test, muscle mass using Dual Energy X-ray Absorptiometry and
        questionnaires will be conducted.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Quadriceps muscle strength assessment
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: Hand-held dynamometer microFET2 (Hoggan Scientific, Salt Lake City UT, USA) will be used to assess lower limb strength and power. Assessment of isometric muscle strength and power will be performed with the participants in a seated position to assess knee extensors and knee flexors. All tests will involve maximal voluntary isometric contractions. Both limbs will be assessed to record side-to-side difference. Two trials were recorded for each muscle group.
  measure: Handgrip strength
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: The handgrip dynamometer will be used to test for the patients' handgrip strength. The handgrip dynamometer is an instrument measuring patients' maximum isometric strength of the hand and forearm muscles. The handle of the dynamometer will be adjusted as the finger is at 90 o whilst the dynamometer is being held. The measurement will be repeated three times and the average calculated for the dominant hand (Hand dominance will be determined by observing the patient's writing hand when signing the informed consent).
  measure: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: The 10-meter timed walking test is a well-established test to assess gait speed. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6-meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
  measure: Chair stand test
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: The chair stand test is a reliable test for assessment for low limb strength in patients. Patients will be asked to sit on a solid chair with arms on shoulders and feet with shoulder width apart. They will be instructed to do 1-2 repetitions to become familiar with the test, and perform as many reputations as they can in 30 seconds.
  measure: Dual Energy X-ray Absorptiometry (DXA)
  time frame: Baseline, 2 months after TKA
  description: The radiation for one session (20 minutes) for sarcopenia assessment is less than 25µSv, which is within the safe range. After every DXA scan, two copies will be printed that show the patients' body composition, bone mineral density, fat percentage, body mass index, and most importantly for this study, lean muscle mass.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: It is a questionnaire that measures a patient's pain, stiffness and physical function and can be summed up into a score out of 96. A high score indicates a more disabled participant .
  measure: Knee Society Score (KSS)
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: Assesses a patient's pain and functionality based on a series of questions interviewed by a clinician. The validated questionnaire combines the objective physician-derived component with a subjective patient-derived component which evaluates pain, functionality, satisfaction, and fulfilment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest .
  measure: Short-Form 12 (SF-12)
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: 12 questions to measure a patient's functional health and well-being from a patient's point of view. It is a reliable and validated measure that summarises the patients' physical and mental health
  measure: International Physical Activity Questionnaire (IPAQ)
  time frame: Baseline, 4 months, 6 months, 2 months after TKA, 6 months after TKA
  description: Assesses and monitors a patient's physical activity and inactivity level. This instrument sums up a patient's activity level per week into three categories, Category 1 Inactivity, category 2 minimally active and category 3 HEPA active
  measure: Nutritional intake questionnaire
  time frame: Baseline
  description: Evaluation of habitual dietary intake will be based on retrospective means of assessment for the past twelve months. A Food Frequency Questionnaire (FFQ) previously validated with data obtained in the Hong Kong Adult Dietary Survey in 1995 as described previously will be used(Appendix 7). Daily dietary intake of Vitamin D and calcium will be evaluated by the Food Processor Nutrition Analysis and Fitness software version 7.9 (Esha Research, Salem, USA), with incorporation of local food composition based on food composition table from China
  arm group label: Intervention group
  arm group type: Experimental
  description: The intervention group will recieve vitamin D supplement for 16 weeks plus standardised 4 weeks prehab for TKR.
  arm group label: Control group
  arm group type: Placebo Comparator
  description: The control group will recieve placebo for 16 weeks plus standardised 4 weeks prehab for TKR.
  intervention type: Drug
  intervention name: Vitamin D
  description: 4000IU/day vitamin D supplement will be used for 16 weeks plus standardised 4 weeks prehabilitation for TKR.
  arm group label: Intervention group
  other name: standardised prehabilitation
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be used for 16 weeks plus standardised 4 weeks prehabilitation for TKR.
  arm group label: Control group
  other name: standardised prehabilitation
  criteria: 
  gender: All
  minimum age: 70 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael Tim-Yun ONG
  role: Principal Investigator
  affiliation: Chinese University of Hong Kong
  facility: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Prof. Tim-Yun Michael ONG
  investigator title: Clinical Assistant Professor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Sarcopenia
  mesh term: Vitamin D Deficiency
  mesh term: Vitamin D
  sharing ipd: Yes
  ipd description: All IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: starting 6 months after publication
  ipd access criteria: Journal reviewer