- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121533
Vitamin D Supplementation in Knee Osteoarthritis (VitD-OA)
The Influence of Vitamin D Supplementation With and Without Glucosamine Sulfate and Omega-3 Fatty Acids in Patients With Osteoarthritis Symptoms
Study Overview
Status
Conditions
Detailed Description
Knee osteoarthritis (OA) is a degenerative joint condition and a leading contributor to the global burden of disease. Estimates indicate that approximately 14 million people in the United States have symptomatic knee OA, and nearly half of those individuals are between 45 and 65 years of age. Over the years, data have extended our knowledge regarding the early premise of knee OA being the sole consequence of "wear and tear" processes of articular cartilage and it is now recognized that knee OA arises, in part, as a consequence of cytokine-mediated cellular and signaling events.
Cytokines are pleiotropic proteins instrumental to the immune response, host defenses, and intra- and inter-cellular signaling. Tumor necrosis factor (TNF)-α and interleukin (IL)-1β are pro-inflammatory cytokines that promote the catabolic and destructive events of knee OA in animal and human studies. These findings are corroborated by data illustrating chondrocytes as a site for pro-inflammatory cytokine production in knee OA, and that disease severity and progression associate with increasing TNF-α, IL-1β, and other cytokine concentrations in the circulation and transcriptional expression in peripheral blood leukocytes. Fortunately, IL-10 is an anti-inflammatory cytokine expressed in chondrocytes and possesses chondroprotective properties by inhibiting pro-inflammatory cytokine production. While some factors are unavoidable or unpreventable, such as aging, trauma, and genetic predisposition, disrupting the cytokine network could alter OA development and progression.
Low circulating vitamin D concentrations are reported in elderly with and without knee osteoarthritis symptoms. Serum 25(OH)D concentrations associate with muscular strength or performance in elderly. Vitamin D supplementation increases serum 25(OH)D concentrations and improves muscular strength in elderly. Based on these observations, vitamin D is essential for muscle function in elderly, however, it is unknown if supplemental vitamin D influences muscular strength in subjects with knee OA. Furthermore, it is probable that a more comprehensive supplement is necessary to improve muscular strength.
The aim of this study is to identify the influence of supplemental vitamin D on circulating cytokines and muscular strength in subjects with knee OA. This study consists of a double-blind, placebo-controlled experimental design. Subjects will be randomly assigned to one of three groups: (#1) vitamin D (cholecalciferol, 4000 IU) with glucosamine sulfate (1000 mg) and omega-3 fatty acids (eicosapentaenoic (EPA, 580 mg) and docosahexaenoic (DHA, 470 mg) acids), (#2) vitamin D (cholecalciferol, 4000 IU) with matching glucosamine sulfate and omega-3 fatty acid placebo supplements, or (#3) matching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements will be taken daily for 84 days (12 weeks). Groups will be permutated in random blocks of six. Serum 25(OH)D, serum cytokines and muscular-based outcomes will be determined prior to, during, and following supplementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Unilateral knee pain, weakness, and impaired physical activity
- Older than 18 years of age but younger than 60 years of age
- Reportedly physically active (minimum of 30 minutes of continuous exercise or physical exertion 3 times per week during the previous year)
Exclusion Criteria:
- Bilateral symptoms of hip, knee or ankle osteoarthritis
- Recent (within 2 years) surgery on the symptomatic or non-symptomatic limb
- History of metabolic bone disease
- History of any skeletal muscle pathologies
- History of cardiac or peripheral cardiovascular system abnormalities
- History of clotting disorders
- History of coronary artery disease, peripheral vascular disease, or stroke
- History of cancer
- Use of warfarin or other anti-coagulants prior to study enrollment
- Use of cholesterol lowering medication
- History of high cholesterol or triglycerides
- History of high blood pressure
- Diagnosed with diabetes mellitus
- Impaired liver function
- Impaired kidney function
- Pregnant
- Daily dietary supplement or vitamin use during the previous year
- Use of corticosteroid medication
- Use of orlistat, phenobarbital, phenytoin, or thiazide
- Morbidly obese (body mass index > 40 kg/m2)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Matching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements.
Supplements taken daily for 84 days (12 weeks).
|
Placebo supplement for vitamin D (cholecalciferol), glucosamine sulfate, and omega-3 fatty acids.
Supplement was taken orally every day for 84-days.
|
EXPERIMENTAL: Vitamin D
Vitamin D (cholecalciferol, 4000 IU) with matching glucosamine sulfate and omega-3 fatty acid placebo supplements.
Supplements taken daily for 84 days (12 weeks).
|
Vitamin D (cholecalciferol).
Supplement was taken orally every day for 84-days.
|
EXPERIMENTAL: Vitamin D, glucosamine sulfate, and omega-3 fatty acids
Vitamin D (cholecalciferol, 4000 IU) with glucosamine sulfate (1000 mg) and omega-3 fatty acids (eicosapentaenoic (EPA, 580 mg) and docosahexaenoic (DHA, 470 mg) acids).
Supplements taken daily for 84 days (12 weeks).
|
Vitamin D (cholecalciferol).
Supplement was taken orally every day for 84-days.
Glucosamine sulfate and omega-3 fatty acids supplement was taken orally every day for 84-days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating (serum) IL-10 concentration
Time Frame: Day 84
|
The influence of supplemental vitamin D on serum IL-10 concentration (pg/mL) in subjects with knee osteoarthritis.
|
Day 84
|
Single-leg peak isokinetic torque
Time Frame: Day 84
|
The influence of supplemental vitamin D on single-leg peak isokinetic torque (Nm at 60 degrees per second) in subjects with knee osteoarthritis.
|
Day 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported pain and physical dysfunction
Time Frame: Day 28 and Day 84
|
Patient reported pain and physical dysfunction (using the subsection questions in the WOMAC survey) will be reported by each subject.
|
Day 28 and Day 84
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating (serum) cytokines (TNF-alpha, IFN-gamma, IL-2, IL-4, IL-5, IL-6, IL-8, IL-12, IL-13, and IL-1beta)
Time Frame: Day 84
|
Supplemental vitamin D influences serum cytokines (pg/mL) in subjects with knee OA
|
Day 84
|
Single leg peak isometric force
Time Frame: Day 84
|
Supplemental vitamin D influences single leg peak isometric force (N) in subjects with knee osteoarthritis.
|
Day 84
|
Circulating (serum) soluble cytokine receptors
Time Frame: Day 84
|
Supplemental vitamin D influences serum soluble cytokine receptors (sIL-1r, sIL-1r2, sIL-4r, sIL-6r, sTNFr1, and sTNFr2: pg/mL)
|
Day 84
|
Single leg peak power output
Time Frame: Day 84
|
Supplemental vitamin D influences single leg peak output (Nm) in subjects with knee osteoarthritis.
|
Day 84
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tyler Barker, PhD, Intermountain Health Care, Inc.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1023358
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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