Osteoarthritis, KneePhase 3VIDEONCT01176344
VItamin D Effect on Osteoarthritis Study
A Phase 3 study testing Vitamin D in people with Osteoarthritis, Knee, run by Menzies Institute for Medical Research at 2 sites in Australia.
Trial summary
Observational evidence suggests that vitamin D deficiency may have a role in the causes of osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There is, however, no evidence which shows that intervening with vitamin D supplementation can slow the progression of OA. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 413 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2010to Dec 2014
- Phase
- Phase 3
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-79 years old;
- Men and women with symptomatic knee osteoarthritis (OA) with a pain visual analogue scale (VAS) of at least 20 mm in most days of the last month;
- Have an American College of Rheumatology (ACR) functional class rating of I, II and III;
- Have relatively good health (0-2 according to the investigator's global assessment of disease status on a 5-point Likert scale, range 0 [very well] to 4 [very poor]);
- Have serum vitamin D level of >12.5 nmol/L and <60 nmol/L;
- Are able to read, speak and understand English, capable of understanding the study requirements and willing to co-operate with the study instructions;
Show all 9Show fewer
- Are able and willing to give informed consent;
- Are willing and able to give blood samples;
- Are willing and able to have knee MRIs performed
Who cannot join
- Have Grade 3 radiographic changes in their knee which is to be investigated;
- Have severe knee pain (more than 80 mm on a 100-mm visual analogue scale,VAS) in most days of the last month;
- Have any contra-indications for having MRIs scans performed;
- Have had significant trauma to the knees including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the screening visit;
- Have ever had knee joint replacement;
- Have anticipated need for knee or hip surgery in the next 2 years;
- Have any stomach or intestinal condition possibly affecting oral drug absorption;
- Have any clinically significant condition(s) such as (but not limited to) rheumatoid arthritis, psoriatic arthritis, lupus, active cancer, cardiac or renal function impairment or hypersensitivity to vitamin D that in the opinion of the investigator may compromise their safety or compliance, interfere with evaluation or preclude completion of the study.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Menzies Research Institute, University of Tasmania
Hobart, Tasmania, 7000
Department of Epidemiology & Preventive Medicine, Monash University
Melbourne, Victoria, 3004
About this study
Official title: Does Vitamin D Supplementation Prevent Progression of Knee Osteoarthritis? A Randomised Controlled Trial
Observational evidence suggests that vitamin D deficiency may have a role in the causes of osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There is, however, no evidence which shows that intervening with vitamin D supplementation can slow the progression of OA. This study is to determine if vitamin D supplementation can reduce knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use of MRI will provide sensitive measures of knee OA changes.
Read the detailed description
Osteoarthritis (OA) is the most common joint disorder in the world. In 2004, OA was estimated to affect over 1.6 million Australians, with total costs of $1.4 billion. OA is the most frequent reason for joint replacement, at a cost of about $1 billion each year. Conventional treatment is palliative and costly, and currently there are no effective medical remedies for OA. These facts have led to 2000-2010 being labelled the Bone and Joint decade, and musculoskeletal disorders being recognised as a National Health Priority. The primary task for OA management should be to identify modifiable risk factors.
Vitamin D deficiency is very common in older people and has been linked with osteoporosis and falls in both older women and men. Emerging data suggests that it also plays an important role in the pathogenesis of knee OA. Firstly, vitamin D may have direct effects on chondrocytes in osteoarthritic cartilage; secondly, chronic vitamin D inadequacy in adults has adverse effects on calcium metabolism, osteoblast activity, matrix ossification and bone density, and thus could impair the ability of bone to respond optimally to pathophysiological processes in OA; and thirdly, low vitamin D levels are associated with loss of muscle strength and muscle mass in older men and women, which may be associated with an increased risk of knee OA. Some observational studies have shown that vitamin D insufficiency is associated with the progression and development of radiographic knee or hip OA. Recently we have demonstrated that baseline serum levels of 25-hydroxy-vitamin D(25-(OH)D) predicts change in cartilage volume in older adults over 2 years, and increases in vitamin D levels are associated with a further protective association. This suggests that vitamin D supplementation may enhance cartilage and bone health, and thus prevent disease progression in patients with knee OA.
The aim of this study is to compare the effects of vitamin D supplementation versus placebo on knee pain and knee structural changes in patients with symptomatic knee osteoarthritis over a 2- year period.
The proposed study design is a randomised, placebo-controlled, double-blind clinical trial. We will recruit 400 subjects (50-79 years old, having relatively good health and serum vitamin D level of <60 and >12.5 nmol/L) with symptomatic knee OA for at least 6 months using a combined strategy in Southern Tasmania and Melbourne. Participants in the intervention arm (n=200) will receive 50,000 IU (1.25 mg) cholecalciferol tablets given once monthly, whilst those in the control arm (n=200) will receive an identical inert placebo. All participants will be provided recommended standard of care. Knee structural changes including knee cartilage volume, cartilage defects, tibial bone area, bone marrow lesions, and meniscal pathology (assessed by MRI), and knee pain at baseline and 2 years later will be determined as outcome measures. Other explanatory factors, such as serum vitamin D levels, height, weight, physical activity, and smoking will also be determined through study period.
Significance:
Observational evidence suggests that vitamin D deficiency may have a role in the progression of OA and there are biologically plausible mechanisms to explain this. However, randomized controlled trials using a sensitive method are required to determine whether intervening with vitamin D supplementation can in fact slow the progression of this disease. In this study, the randomized, placebo-controlled, double-blind design, and the use of MRI to provide sensitive and precise measures of knee structural change will ensure a rigorous evaluation of the impact of vitamin D supplementation on knee OA. It will be the first long term clinical trial to determine comprehensively the effects on knee structural changes (cartilage, bone) utilizing the pioneering MRI techniques and limb muscle strength assessment. This study builds upon previous clinical and epidemiological studies that supports the objectives of the Bone and Joint Decade organization and addresses a National Health Priority Area.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D supplementation, Osteoarthritis, Knee, Randomised clinical trial (RCT), Cartilage, MRI
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
50,000 IU (1.25 mg) cholecalciferol capsules once monthly for 2 years
PlaceboDrug
Inert placebo capsules once monthly for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | Participants in the intervention arm will receive 50,000 IU (1.25 mg) cholecalciferol capsules given once monthly Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | The control arm will receive identical inert placebo capsules given once monthly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of knee cartilage volume
Cartilage volume will be assessed using magnetic resonance imaging (MRI)
Measured: Over 2 years (Cartilage volume will be assessed at baseline and 2 years later)
Change in knee pain
Assessed using WOMAC
Measured: Over 2 years
Secondary outcomes (7)
Progression of knee cartilage defects
Knee cartilage defects will be measured using MRI.
Measured: Over 2 years (Cartilahe defects will be measured at baseline and 2 years later)
Change in bone marrow lesions
Assessed using MRI
Measured: Over 2 years
Change in knee pain
Assessed using VAS
Measured: Over 2 years
Change in physical function
Assessed using WOMAC function
Measured: Over 2 years
Change in joint effusion
Assessed using MRI
Measured: Over 2 years
Central blood pressure
Radial applanation tonometry
Measured: one year
Aortic stiffness
Carotid to femoral pulse wave velocity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, Changhai Ding, Menzies Institute for Medical Research
- Investigators
- Changhai Ding, MD, Principal investigator, Menzies Research Institute & Monash UniversityGraeme Jones, MD, Principal investigator, Menzies Institute for Medical ResearchFlavia M Cicuttini, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176344
- Sponsor's protocol ID
- VIDEO605501
- Acronym
- VIDEO
- Status last verified
- Sep 2015
- First submitted
- 4 Aug 2010
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ding C, Cicuttini F, Parameswaran V, Burgess J, Quinn S, Jones G. Serum levels of vitamin D, sunlight exposure, and knee cartilage loss in older adults: the Tasmanian older adult cohort study. Arthritis Rheum. 2009 May;60(5):1381-9. doi: 10.1002/art.24486.
PubMed 19404958Wang T, Zheng S, Jin X, Cen H, Zhu Z, Han W, Wluka A, Cicuttini F, Cao P, Ding C. Baseline 25-hydroxyvitamin D levels predict the effects of vitamin D supplementation on joint symptoms and cartilage loss in patients with knee osteoarthritis. Rheumatol Adv Pract. 2025 May 27;9(3):rkaf061. doi: 10.1093/rap/rkaf061. eCollection 2025.
PubMed 40677617Chang J, Chen T, Yan Y, Zhu Z, Han W, Zhao Y, Antony B, Wluka A, Winzenberg T, Cicuttini F, Ding C. Associations between the morphological parameters of proximal tibiofibular joint (PTFJ) and changes in tibiofemoral joint structures in patients with knee osteoarthritis. Arthritis Res Ther. 2022 Jan 27;24(1):34. doi: 10.1186/s13075-022-02719-8.
PubMed 35086561Zheng S, Tu L, Cicuttini F, Zhu Z, Han W, Antony B, Wluka AE, Winzenberg T, Aitken D, Blizzard L, Jones G, Ding C. Depression in patients with knee osteoarthritis: risk factors and associations with joint symptoms. BMC Musculoskelet Disord. 2021 Jan 7;22(1):40. doi: 10.1186/s12891-020-03875-1.
PubMed 33413273Tu L, Zheng S, Cicuttini F, Jin X, Han W, Zhu Z, Antony B, Winzenberg T, Jones G, Gu J, Wluka AE, Ding C. Effects of Vitamin D Supplementation on Disabling Foot Pain in Patients With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2021 Jun;73(6):781-787. doi: 10.1002/acr.24371.
PubMed 32623812Cuellar WA, Blizzard L, Hides JA, Callisaya ML, Jones G, Cicuttini F, Wluka AE, Ding C, Winzenberg TM. Vitamin D supplements for trunk muscle morphology in older adults: secondary analysis of a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):177-187. doi: 10.1002/jcsm.12364. Epub 2018 Nov 22.
PubMed 30565892Wang X, Jin X, Blizzard L, Antony B, Han W, Zhu Z, Cicuttini F, Wluka AE, Winzenberg T, Jones G, Ding C. Associations Between Knee Effusion-synovitis and Joint Structural Changes in Patients with Knee Osteoarthritis. J Rheumatol. 2017 Nov;44(11):1644-1651. doi: 10.3899/jrheum.161596. Epub 2017 Sep 1.
PubMed 28864651Zhu Z, Otahal P, Wang B, Jin X, Laslett LL, Wluka AE, Antony B, Han W, Wang X, Winzenberg T, Cicuttini F, Jones G, Ding C. Cross-sectional and longitudinal associations between serum inflammatory cytokines and knee bone marrow lesions in patients with knee osteoarthritis. Osteoarthritis Cartilage. 2017 Apr;25(4):499-505. doi: 10.1016/j.joca.2016.10.024. Epub 2016 Nov 9.
PubMed 27836676Jin X, Jones G, Cicuttini F, Wluka A, Zhu Z, Han W, Antony B, Wang X, Winzenberg T, Blizzard L, Ding C. Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2016 Mar 8;315(10):1005-13. doi: 10.1001/jama.2016.1961.
PubMed 26954409Zhu Z, Jin X, Wang B, Wluka A, Antony B, Laslett LL, Winzenberg T, Cicuttini F, Jones G, Ding C. Cross-Sectional and Longitudinal Associations Between Serum Levels of High-Sensitivity C-Reactive Protein, Knee Bone Marrow Lesions, and Knee Pain in Patients With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2016 Oct;68(10):1471-7. doi: 10.1002/acr.22834. Epub 2016 Sep 6.
PubMed 26748954Veloudi P, Blizzard CL, Ding CH, Cicuttini FM, Jin X, Wluka AE, Winzenberg T, Jones G, Sharman JE. Effect of Vitamin D Supplementation on Aortic Stiffness and Arterial Hemodynamics in People With Osteoarthritis and Vitamin D Deficiency. J Am Coll Cardiol. 2015 Dec 15;66(23):2679-2681. doi: 10.1016/j.jacc.2015.10.007. No abstract available.
PubMed 26670070Cao Y, Jones G, Cicuttini F, Winzenberg T, Wluka A, Sharman J, Nguo K, Ding C. Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2012 Aug 6;13:131. doi: 10.1186/1745-6215-13-131.
PubMed 22867111
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vitamin D Supplementation Prevent Progression of Knee Osteoarthritis? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01176344
- Acronym / sponsor ID
- VIDEO / VIDEO605501
- Conditions
- Osteoarthritis, Knee
- Keywords
- Vitamin D supplementation, Osteoarthritis, Knee, Randomised clinical trial (RCT), Cartilage, MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Menzies Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Aug 2010 (estimated)
- 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.
Observational evidence suggests that vitamin D deficiency may have a role in the causes of osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There is, however, no evidence which shows that intervening with vitamin D supplementation can slow the progression of OA. This study is to determine if vitamin D supplementation can reduce knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use of MRI will provide sensitive measures of knee OA changes.
Detailed description
Osteoarthritis (OA) is the most common joint disorder in the world. In 2004, OA was estimated to affect over 1.6 million Australians, with total costs of $1.4 billion. OA is the most frequent reason for joint replacement, at a cost of about $1 billion each year. Conventional treatment is palliative and costly, and currently there are no effective medical remedies for OA. These facts have led to 2000-2010 being labelled the Bone and Joint decade, and musculoskeletal disorders being recognised as a National Health Priority. The primary task for OA management should be to identify modifiable risk factors.
Vitamin D deficiency is very common in older people and has been linked with osteoporosis and falls in both older women and men. Emerging data suggests that it also plays an important role in the pathogenesis of knee OA. Firstly, vitamin D may have direct effects on chondrocytes in osteoarthritic cartilage; secondly, chronic vitamin D inadequacy in adults has adverse effects on calcium metabolism, osteoblast activity, matrix ossification and bone density, and thus could impair the ability of bone to respond optimally to pathophysiological processes in OA; and thirdly, low vitamin D levels are associated with loss of muscle strength and muscle mass in older men and women, which may be associated with an increased risk of knee OA. Some observational studies have shown that vitamin D insufficiency is associated with the progression and development of radiographic knee or hip OA. Recently we have demonstrated that baseline serum levels of 25-hydroxy-vitamin D(25-(OH)D) predicts change in cartilage volume in older adults over 2 years, and increases in vitamin D levels are associated with a further protective association. This suggests that vitamin D supplementation may enhance cartilage and bone health, and thus prevent disease progression in patients with knee OA.
The aim of this study is to compare the effects of vitamin D supplementation versus placebo on knee pain and knee structural changes in patients with symptomatic knee osteoarthritis over a 2- year period.
The proposed study design is a randomised, placebo-controlled, double-blind clinical trial. We will recruit 400 subjects (50-79 years old, having relatively good health and serum vitamin D level of <60 and >12.5 nmol/L) with symptomatic knee OA for at least 6 months using a combined strategy in Southern Tasmania and Melbourne. Participants in the intervention arm (n=200) will receive 50,000 IU (1.25 mg) cholecalciferol tablets given once monthly, whilst those in the control arm (n=200) will receive an identical inert placebo. All participants will be provided recommended standard of care. Knee structural changes including knee cartilage volume, cartilage defects, tibial bone area, bone marrow lesions, and meniscal pathology (assessed by MRI), and knee pain at baseline and 2 years later will be determined as outcome measures. Other explanatory factors, such as serum vitamin D levels, height, weight, physical activity, and smoking will also be determined through study period.
Significance:
Observational evidence suggests that vitamin D deficiency may have a role in the progression of OA and there are biologically plausible mechanisms to explain this. However, randomized controlled trials using a sensitive method are required to determine whether intervening with vitamin D supplementation can in fact slow the progression of this disease. In this study, the randomized, placebo-controlled, double-blind design, and the use of MRI to provide sensitive and precise measures of knee structural change will ensure a rigorous evaluation of the impact of vitamin D supplementation on knee OA. It will be the first long term clinical trial to determine comprehensively the effects on knee structural changes (cartilage, bone) utilizing the pioneering MRI techniques and limb muscle strength assessment. This study builds upon previous clinical and epidemiological studies that supports the objectives of the Bone and Joint Decade organization and addresses a National Health Priority Area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Drug: Vitamin DParticipants in the intervention arm will receive 50,000 IU (1.25 mg) cholecalciferol capsules given once monthly |
| Placebo | Placebo comparator | Drug: PlaceboThe control arm will receive identical inert placebo capsules given once monthly. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 50-79 years old;
- Men and women with symptomatic knee osteoarthritis (OA) with a pain visual analogue scale (VAS) of at least 20 mm in most days of the last month;
- Have an American College of Rheumatology (ACR) functional class rating of I, II and III;
- Have relatively good health (0-2 according to the investigator's global assessment of disease status on a 5-point Likert scale, range 0 [very well] to 4 [very poor]);
- Have serum vitamin D level of >12.5 nmol/L and <60 nmol/L;
Key exclusion criteria (8 listed)
- Have Grade 3 radiographic changes in their knee which is to be investigated;
- Have severe knee pain (more than 80 mm on a 100-mm visual analogue scale,VAS) in most days of the last month;
- Have any contra-indications for having MRIs scans performed;
- Have had significant trauma to the knees including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the screening visit;
- Have ever had knee joint replacement;
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 D50,000 IU (1.25 mg) cholecalciferol capsules once monthly for 2 years | Drug | Vitamin D supplementation |
| PlaceboInert placebo capsules once monthly for 2 years. | Drug | Placebo |
Primary outcome
Loss of knee cartilage volume
Time frame: Over 2 years (Cartilage volume will be assessed at baseline and 2 years later)
Cartilage volume will be assessed using magnetic resonance imaging (MRI)
Change in knee pain
Time frame: Over 2 years
Assessed using WOMAC
7 secondary outcomes
Progression of knee cartilage defects
Time frame: Over 2 years (Cartilahe defects will be measured at baseline and 2 years later)
Change in bone marrow lesions
Time frame: Over 2 years
Change in knee pain
Time frame: Over 2 years
Change in physical function
Time frame: Over 2 years
Change in joint effusion
Time frame: Over 2 years
Central blood pressure
Time frame: one year
Aortic stiffness
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Background: PubMed 19404958Ding C, Cicuttini F, Parameswaran V, Burgess J, Quinn S, Jones G. Serum levels of vitamin D, sunlight exposure, and knee cartilage loss in older adults: the Tasmanian older adult cohort study. Arthritis Rheum. 2009 May;60(5):1381-9. doi: 10.1002/art.24486.
- Derived from this study: PubMed 40677617Wang T, Zheng S, Jin X, Cen H, Zhu Z, Han W, Wluka A, Cicuttini F, Cao P, Ding C. Baseline 25-hydroxyvitamin D levels predict the effects of vitamin D supplementation on joint symptoms and cartilage loss in patients with knee osteoarthritis. Rheumatol Adv Pract. 2025 May 27;9(3):rkaf061. doi: 10.1093/rap/rkaf061. eCollection 2025.
- Derived from this study: PubMed 35086561Chang J, Chen T, Yan Y, Zhu Z, Han W, Zhao Y, Antony B, Wluka A, Winzenberg T, Cicuttini F, Ding C. Associations between the morphological parameters of proximal tibiofibular joint (PTFJ) and changes in tibiofemoral joint structures in patients with knee osteoarthritis. Arthritis Res Ther. 2022 Jan 27;24(1):34. doi: 10.1186/s13075-022-02719-8.
- Derived from this study: PubMed 33413273Zheng S, Tu L, Cicuttini F, Zhu Z, Han W, Antony B, Wluka AE, Winzenberg T, Aitken D, Blizzard L, Jones G, Ding C. Depression in patients with knee osteoarthritis: risk factors and associations with joint symptoms. BMC Musculoskelet Disord. 2021 Jan 7;22(1):40. doi: 10.1186/s12891-020-03875-1.
- Derived from this study: PubMed 32623812Tu L, Zheng S, Cicuttini F, Jin X, Han W, Zhu Z, Antony B, Winzenberg T, Jones G, Gu J, Wluka AE, Ding C. Effects of Vitamin D Supplementation on Disabling Foot Pain in Patients With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2021 Jun;73(6):781-787. doi: 10.1002/acr.24371.
- Derived from this study: PubMed 30565892Cuellar WA, Blizzard L, Hides JA, Callisaya ML, Jones G, Cicuttini F, Wluka AE, Ding C, Winzenberg TM. Vitamin D supplements for trunk muscle morphology in older adults: secondary analysis of a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):177-187. doi: 10.1002/jcsm.12364. Epub 2018 Nov 22.
- Derived from this study: PubMed 28864651Wang X, Jin X, Blizzard L, Antony B, Han W, Zhu Z, Cicuttini F, Wluka AE, Winzenberg T, Jones G, Ding C. Associations Between Knee Effusion-synovitis and Joint Structural Changes in Patients with Knee Osteoarthritis. J Rheumatol. 2017 Nov;44(11):1644-1651. doi: 10.3899/jrheum.161596. Epub 2017 Sep 1.
- Derived from this study: PubMed 27836676Zhu Z, Otahal P, Wang B, Jin X, Laslett LL, Wluka AE, Antony B, Han W, Wang X, Winzenberg T, Cicuttini F, Jones G, Ding C. Cross-sectional and longitudinal associations between serum inflammatory cytokines and knee bone marrow lesions in patients with knee osteoarthritis. Osteoarthritis Cartilage. 2017 Apr;25(4):499-505. doi: 10.1016/j.joca.2016.10.024. Epub 2016 Nov 9.
- Derived from this study: PubMed 26954409Jin X, Jones G, Cicuttini F, Wluka A, Zhu Z, Han W, Antony B, Wang X, Winzenberg T, Blizzard L, Ding C. Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2016 Mar 8;315(10):1005-13. doi: 10.1001/jama.2016.1961.
- Derived from this study: PubMed 26748954Zhu Z, Jin X, Wang B, Wluka A, Antony B, Laslett LL, Winzenberg T, Cicuttini F, Jones G, Ding C. Cross-Sectional and Longitudinal Associations Between Serum Levels of High-Sensitivity C-Reactive Protein, Knee Bone Marrow Lesions, and Knee Pain in Patients With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2016 Oct;68(10):1471-7. doi: 10.1002/acr.22834. Epub 2016 Sep 6.
- Derived from this study: PubMed 26670070Veloudi P, Blizzard CL, Ding CH, Cicuttini FM, Jin X, Wluka AE, Winzenberg T, Jones G, Sharman JE. Effect of Vitamin D Supplementation on Aortic Stiffness and Arterial Hemodynamics in People With Osteoarthritis and Vitamin D Deficiency. J Am Coll Cardiol. 2015 Dec 15;66(23):2679-2681. doi: 10.1016/j.jacc.2015.10.007. No abstract available.
- Derived from this study: PubMed 22867111Cao Y, Jones G, Cicuttini F, Winzenberg T, Wluka A, Sharman J, Nguo K, Ding C. Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2012 Aug 6;13:131. doi: 10.1186/1745-6215-13-131.
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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.
Changhai Ding, MD principal investigator
Menzies Research Institute & Monash University
Graeme Jones, MD principal investigator
Menzies Institute for Medical Research
Flavia M Cicuttini, PhD principal investigator
Monash University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Osteoarthritis, Knee, run by Menzies Institute for Medical Research at 2 sites in Australia.
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 9 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: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of knee cartilage volume (time frame: Over 2 years (Cartilage volume will be assessed at baseline and 2 years later)). The study lists 2 primary outcomes in all. 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 NCT01176344, which also lists 12 linked publications.
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 9 Sep 2015; AzTrials last refreshed its copy on 28 Oct 2026.