Vitamin D Supplementation in Knee Osteoarthritis

NCT04121533 | Completed

• 1 other identifier: 1023358
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Vitamin D Supplementation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Patient reported pain and physical dysfunction

  Day 28 and Day 84

Other Outcomes (4)

• Circulating (serum) cytokines (TNF-alpha, IFN-gamma, IL-2, IL-4, IL-5, IL-6, IL-8, IL-12, IL-13, and IL-1beta)

  Day 84

• Single leg peak isometric force

  Day 84

• Circulating (serum) soluble cytokine receptors

  Day 84

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements taken daily for 84 days (12 weeks).

Dietary Supplement: Placebo

Vitamin D

EXPERIMENTAL

Vitamin D (cholecalciferol, 4000 IU) with matching glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements taken daily for 84 days (12 weeks).

Dietary Supplement: Vitamin D (cholecalciferol)

Vitamin D, glucosamine sulfate, and omega-3 fatty acids

EXPERIMENTAL

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).

Dietary Supplement: Vitamin D (cholecalciferol); Dietary Supplement: Glucosamine sulfate and omega-3 fatty acids

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo supplement for vitamin D (cholecalciferol), glucosamine sulfate, and omega-3 fatty acids. Supplement was taken orally every day for 84-days.

Placebo

Vitamin D (cholecalciferol) DIETARY_SUPPLEMENT

Vitamin D (cholecalciferol). Supplement was taken orally every day for 84-days.

Vitamin D; Vitamin D, glucosamine sulfate, and omega-3 fatty acids

Glucosamine sulfate and omega-3 fatty acids DIETARY_SUPPLEMENT

Glucosamine sulfate and omega-3 fatty acids supplement was taken orally every day for 84-days.

Vitamin D, glucosamine sulfate, and omega-3 fatty acids

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• USANA Health Sciences: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Cholecalciferol; Glucosamine; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Hexosamines; Amino Sugars; Carbohydrates; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Tyler Barker, PhD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 permuted in random blocks of six.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 10, 2019
• Study Start: July 28, 2011
• Primary Completion: January 8, 2013
• Study Completion: January 8, 2013
• Last Updated: October 10, 2019

Record last verified: 2019-10