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VItamin D Effect on Osteoarthritis Study

NCT01176344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2015-09-09

No results posted yet for this study

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

Interventions

DRUG

Vitamin D

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

DRUG

Placebo

Inert placebo capsules once monthly for 2 years.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Menzies Institute for Medical Research

    lead OTHER

Principal Investigators

  • Changhai Ding, MD · Menzies Research Institute & Monash University

  • Graeme Jones, MD · Menzies Institute for Medical Research

  • Flavia M Cicuttini, PhD · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176344 on ClinicalTrials.gov