Osteoarthritis, Knee Clinical Trial
— VitD-OAOfficial title:
The Influence of Vitamin D Supplementation With and Without Glucosamine Sulfate and Omega-3 Fatty Acids in Patients With Osteoarthritis Symptoms
NCT number | NCT04121533 |
Other study ID # | 1023358 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2011 |
Est. completion date | January 8, 2013 |
Verified date | October 2019 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Muscular (i.e., quadriceps) weakness is a major risk factor for predisposing the knee to osteoarthritis, impairing physical function, and increasing patient-reported pain. Muscular weakness is a consequence of and could contribute to the development of knee osteoarthritis. Minimizing muscular weakness has been fount to improve activities of daily living in patients with osteoarthritis symptoms. Although vitamin D associates with muscular strength in young and old populations, it is unknown if vitamin D supplementation improves muscular strength in subjects with osteoarthritis or osteoarthritis symptoms. It is also unknown if supplemental vitamin D alters circulating cytokine concentrations in subjects with knee osteoarthritis. Furthermore, it is probable that a more comprehensive supplement is necessary to improve muscular strength. Such as glucosamine sulfate and omega-3 fatty acids (i.e., eicosapentaenoic and docosahexaenoic acids) which could be influential on knee pain and inflammation as well as muscular strength. Therefore, the purpose of this study is to identify the influence of vitamin D supplementation with and without glucosamine sulfate and omega-3 fatty acids on circulating cytokine concentrations and muscular strength in subjects with knee osteoarthritis symptoms. This study is intended to establish preliminary data identifying the influence of vitamin D supplementation on circulating cytokines and muscular strength in subjects with osteoarthritis at no more than minimal risk exposure to subjects.
Status | Completed |
Enrollment | 73 |
Est. completion date | January 8, 2013 |
Est. primary completion date | January 8, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Intermountain Health Care, Inc. | USANA Health Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circulating (serum) cytokines (TNF-alpha, IFN-gamma, IL-2, IL-4, IL-5, IL-6, IL-8, IL-12, IL-13, and IL-1beta) | Supplemental vitamin D influences serum cytokines (pg/mL) in subjects with knee OA | Day 84 | |
Other | Single leg peak isometric force | Supplemental vitamin D influences single leg peak isometric force (N) in subjects with knee osteoarthritis. | Day 84 | |
Other | Circulating (serum) soluble cytokine receptors | Supplemental vitamin D influences serum soluble cytokine receptors (sIL-1r, sIL-1r2, sIL-4r, sIL-6r, sTNFr1, and sTNFr2: pg/mL) | Day 84 | |
Other | Single leg peak power output | Supplemental vitamin D influences single leg peak output (Nm) in subjects with knee osteoarthritis. | Day 84 | |
Primary | Circulating (serum) IL-10 concentration | The influence of supplemental vitamin D on serum IL-10 concentration (pg/mL) in subjects with knee osteoarthritis. | Day 84 | |
Primary | Single-leg peak isokinetic torque | 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 | Patient reported pain and physical dysfunction | 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 |
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