Vitamin D DeficiencyNCT05981534
The Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis
A study testing Vitamin D in people with Vitamin D Deficiency and Sarcopenia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vitamin D Deficiency, Sarcopenia, Knee Osteoarthritis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Mar 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged over 50 with end-stage knee OA
- Patient are on the waiting list for TKR at Prince of Wales Hospital
- Walk unaided for 6 meters
- Able to comply with the assessments and has given oral and written consent
- Patients with vitamin D insufficiency and deficiency at the baseline measurement (25(OH)D <30 ng/mL)
Who cannot join
- Patients with connective tissue disorders or myositis condition
- History of any Hip \& Knee surgery
- Patients with malnutrition were assessed by Mini-Nutritional assessment.
- Patients with acute immobility (i.e., post-hip fracture or post-acute hospital admission)
- Patient scheduled for TKR within six months
- Patients already taking vitamin D supplements
- Patients with a known contraindication to vitamin D treatment (such as allergy)
- Patients who have renal impairment with glomerular filtration rate (eGFR) < 30 ml/minute
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Michael Tim-Yun ONG, 26364171, michael.ong@cuhk.edu.hk
About this study
Official title: Double-blinded Randomized Controlled Trial Investigating the Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis
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.
Low vitamin D can adversely affect cartilage thickness and study suggested that low serum vitamin D is associated with increased radiographic knee OA progression. A systematic review concluded that vitamin D supplements can improve pain and function in patients with knee OA.
Read more
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.
One 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.
This will be a double-blinded RCT investigating the effect of vitamin D supplements or knee muscle strength, physical function, pain symptoms and, sarcopenia status. The study will be a follow-up study with assessment at baseline, 3- ,6-and 12-months post vitamin D intervention.
Read the detailed description
Osteoarthritis (OA) knee is one of the common chronic degenerative conditions. It causes disability in elders, leading to pain and stiffness. The prevalence of radiologic knee osteoarthritis and symptomatic knee OA were 37.4% and 12.1% among adults over 60 years of age.
Often, patients with end-stage knee OA often adopt a sedentary lifestyle to avoid joint pain and stiffness. This can have an adverse effect on muscle function both locally around the knees as well as on generalized muscle health. Ageing and inactivity leads to a progressive loss of muscle mass and strength until an abnormally low level, termed "sarcopenia". Sarcopenic elderlies are more likely to develop deterioration of functional outcomes and higher mortality resulting in socioeconomic and healthcare burdens. In contrast, our previous study investigating the prevalence of sarcopenia in end-stage OA showed that 32.8% of severe knee OA patients also suffered sarcopenia, and these patients showed a slower recovery after undergoing TKR.
Vitamin D has long been recognized for its effect on musculoskeletal health, and increasing attention has been focused on its effect on muscle function. Vitamin D directly affects muscle hypertrophy by acting on specific vitamin D receptors (VDRs) in myocytes, and sufficient vitamin D levels in patients have been found to correlate with an increase in the size, number, and strength of muscle fibers. In the Chinese population aged over 65, 30.6% of the population studied presented with vitamin D deficiency (25(OH)D <20 ng/mL). A systematic review concluded that vitamin D supplements can improve pain and function in patients with knee OA. Moreover, patients with end stage OA knees will have more pain, leading to decreased mobility, a higher risk of sarcopenia, and vitamin D insufficiency that would warrant attention.
56 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. All study tablets including the placebo will be manufactured according to Good Manufacturing Practice (GMP) guidelines for quality assurance.
Assessments including quadriceps and hamstring 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.
- Conditions
- Vitamin D Deficiency, Sarcopenia, Knee Osteoarthritis
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Sarcopenia, Muscle atrophy, Knee Osteoarthritis
- Medical subject headings
- Vitamin D Deficiency, Sarcopenia, Osteoarthritis, Knee, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called SODX Co., Ltd, Osaka, Japan
4000IU/day vitamin D supplement will be used for 6 months
PlaceboDrug
Also called SODX Co., Ltd, Osaka, Japan
Placebo will be used for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive vitamin D supplement for 6 months Receives: Drug: Vitamin D |
| Control group | Placebo comparator | The control group will receive placebo for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps and hamstring muscle strength assessment
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.
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Secondary outcomes (12)
The 6-meter timed walking test
The 6-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).
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
5-time Chair stand test
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.
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Dual Energy X-ray Absorptiometry (DXA)
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.
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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 .
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Knee Injury and Osteoarthritis Outcome Score (KOOS)
To to evaluate symptoms and function in patients with knee injury and osteoarthritis with five separately scored subscales. Higher scores means better knee function
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Short-Form 36 (SF-36)
36 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. Higher scores means better quality of life.
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
International Physical Activity Questionnaire (IPAQ)
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
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Nutritional intake questionnaire
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
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Sunlight exposure questionnaire
The Chinese version of the sunlight exposure questionnaire will be used in this study and has proven to be adequate for measurement of lifetime sunlight exposure among Hong Kong Chinese women. Higher scores means high chance of level vitamin D level.
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Handgrip strength
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).
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Serum myokine evaluation
Blood taking (5 ml) will be performed. The serum will be prepared by centrifugation and kept in a -80º freezer until use. Quantitative analysis for myokines and proteins related to muscle metabolism will be performed by Human Myokine Magnetic Bead Panel (Millipore) with Bioplex-200 bead-based suspension assay system (LKSIHS core facilities) or enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Serum vitamin D assays
Serum 25(OH)Vit-D levels will be measured by a commercial 25(OH) Vitamin D ELISA kit (Abcam ab213966) according to the manufacturer's instruction, providing the quantitative determination of 25(OH) Vitamin D3 and 25(OH) Vitamin D2
Measured: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start17 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
- Investigators
- Michael Tim-Yun ONG, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981534
- Sponsor's protocol ID
- 2022.252
- Status last verified
- Mar 2024
- First submitted
- 31 Jul 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Wang QW, Ong MT, Man GC, Yeung YM, He X, Choi BC, Ng JP, Mok DK, Lam TP, Yung PS. The effectiveness of vitamin D supplementation in patients with end-stage knee osteoarthritis: Study protocol for a double-blinded, randomized controlled trial. PLoS One. 2024 Oct 21;19(10):e0309610. doi: 10.1371/journal.pone.0309610. eCollection 2024.
PubMed 39432457
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Randomized Controlled Trial Investigating the Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05981534
- Acronym / sponsor ID
- 2022.252
- Conditions
- Vitamin D Deficiency, Sarcopenia, Knee Osteoarthritis
- Keywords
- Vitamin D, Sarcopenia, Muscle atrophy, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 17 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Low vitamin D can adversely affect cartilage thickness and study suggested that low serum vitamin D is associated with increased radiographic knee OA progression. 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.
One 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.
This will be a double-blinded RCT investigating the effect of vitamin D supplements or knee muscle strength, physical function, pain symptoms and, sarcopenia status. The study will be a follow-up study with assessment at baseline, 3- ,6-and 12-months post vitamin D intervention.
Detailed description
Osteoarthritis (OA) knee is one of the common chronic degenerative conditions. It causes disability in elders, leading to pain and stiffness. The prevalence of radiologic knee osteoarthritis and symptomatic knee OA were 37.4% and 12.1% among adults over 60 years of age.
Often, patients with end-stage knee OA often adopt a sedentary lifestyle to avoid joint pain and stiffness. This can have an adverse effect on muscle function both locally around the knees as well as on generalized muscle health. Ageing and inactivity leads to a progressive loss of muscle mass and strength until an abnormally low level, termed "sarcopenia". Sarcopenic elderlies are more likely to develop deterioration of functional outcomes and higher mortality resulting in socioeconomic and healthcare burdens. In contrast, our previous study investigating the prevalence of sarcopenia in end-stage OA showed that 32.8% of severe knee OA patients also suffered sarcopenia, and these patients showed a slower recovery after undergoing TKR.
Vitamin D has long been recognized for its effect on musculoskeletal health, and increasing attention has been focused on its effect on muscle function. Vitamin D directly affects muscle hypertrophy by acting on specific vitamin D receptors (VDRs) in myocytes, and sufficient vitamin D levels in patients have been found to correlate with an increase in the size, number, and strength of muscle fibers. In the Chinese population aged over 65, 30.6% of the population studied presented with vitamin D deficiency (25(OH)D <20 ng/mL). A systematic review concluded that vitamin D supplements can improve pain and function in patients with knee OA. Moreover, patients with end stage OA knees will have more pain, leading to decreased mobility, a higher risk of sarcopenia, and vitamin D insufficiency that would warrant attention.
56 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. All study tablets including the placebo will be manufactured according to Good Manufacturing Practice (GMP) guidelines for quality assurance.
Assessments including quadriceps and hamstring 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Vitamin DThe intervention group will receive vitamin D supplement for 6 months |
| Control group | Placebo comparator | Drug: PlaceboThe control group will receive placebo for 6 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients aged over 50 with end-stage knee OA
- Patient are on the waiting list for TKR at Prince of Wales Hospital
- Walk unaided for 6 meters
- Able to comply with the assessments and has given oral and written consent
- Patients with vitamin D insufficiency and deficiency at the baseline measurement (25(OH)D <30 ng/mL)
Key exclusion criteria (8 listed)
- Patients with connective tissue disorders or myositis condition
- History of any Hip \& Knee surgery
- Patients with malnutrition were assessed by Mini-Nutritional assessment.
- Patients with acute immobility (i.e., post-hip fracture or post-acute hospital admission)
- Patient scheduled for TKR within six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: SODX Co., Ltd, Osaka, Japan4000IU/day vitamin D supplement will be used for 6 months | Drug | Intervention group |
| PlaceboAlso: SODX Co., Ltd, Osaka, JapanPlacebo will be used for 6 months | Drug | Control group |
Primary outcome
Quadriceps and hamstring muscle strength assessment
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
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.
12 secondary outcomes
The 6-meter timed walking test
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
5-time Chair stand test
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Dual Energy X-ray Absorptiometry (DXA)
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Short-Form 36 (SF-36)
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Nutritional intake questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Sunlight exposure questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Handgrip strength
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Serum myokine evaluation
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Serum vitamin D assays
Time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 39432457Wang QW, Ong MT, Man GC, Yeung YM, He X, Choi BC, Ng JP, Mok DK, Lam TP, Yung PS. The effectiveness of vitamin D supplementation in patients with end-stage knee osteoarthritis: Study protocol for a double-blinded, randomized controlled trial. PLoS One. 2024 Oct 21;19(10):e0309610. doi: 10.1371/journal.pone.0309610. eCollection 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Tim-Yun ONG principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency and Sarcopenia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tim-Yun ONG, MSc (26364171, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps and hamstring muscle strength assessment (time frame: Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.