VItamin D Effect on Osteoarthritis Study

NCT01176344 | Completed Phase 3

• 1 other identifier: VIDEO605501
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Osteoarthritis, Knee

Keywords

Vitamin D supplementation; Osteoarthritis; Knee; Randomised clinical trial (RCT); Cartilage; MRI

Outcome Measures

Primary Outcomes (2)

• Loss of knee cartilage volume

  Cartilage volume will be assessed using magnetic resonance imaging (MRI)

  Over 2 years (Cartilage volume will be assessed at baseline and 2 years later)

• Change in knee pain

  Assessed using WOMAC

  Over 2 years

Secondary Outcomes (7)

• Progression of knee cartilage defects

  Over 2 years (Cartilahe defects will be measured at baseline and 2 years later)

• Change in bone marrow lesions

  Over 2 years

• Change in knee pain

  Over 2 years

• Change in physical function

  Over 2 years

• Change in joint effusion

  Over 2 years

Study Arms (2)

Vitamin D supplementation

EXPERIMENTAL

Participants in the intervention arm will receive 50,000 IU (1.25 mg) cholecalciferol capsules given once monthly

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

The control arm will receive identical inert placebo capsules given once monthly.

Drug: Placebo

Interventions

Vitamin D DRUG

50,000 IU (1.25 mg) cholecalciferol capsules once monthly for 2 years

Vitamin D supplementation

Placebo DRUG

Inert placebo capsules once monthly for 2 years.

Placebo

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menzies Institute for Medical Research: lead
• Monash University: collaborator

Study Sites (2)

Menzies Research Institute, University of Tasmania

Hobart, Tasmania, 7000, Australia

Location

Department of Epidemiology & Preventive Medicine, Monash University

Melbourne, Victoria, 3004, Australia

Location

Related Publications (12)

• 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.

  PMID: 19404958 BACKGROUND

• Wang 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.

  PMID: 40677617 DERIVED

• Chang 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.

  PMID: 35086561 DERIVED

• Zheng 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.

  PMID: 33413273 DERIVED

• Tu 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.

  PMID: 32623812 DERIVED

• Cuellar 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.

  PMID: 30565892 DERIVED

• Wang 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.

  PMID: 28864651 DERIVED

• Zhu 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.

  PMID: 27836676 DERIVED

• Jin 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.

  PMID: 26954409 DERIVED

• Zhu 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.

  PMID: 26748954 DERIVED

• Veloudi 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.

  PMID: 26670070 DERIVED

• Cao 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.

  PMID: 22867111 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Changhai Ding, MD

  Menzies Research Institute & Monash University

  PRINCIPAL INVESTIGATOR

• Graeme Jones, MD

  Menzies Institute for Medical Research

  PRINCIPAL INVESTIGATOR

• Flavia M Cicuttini, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

AU (2)