Osteoarthritis, KneeVitD-OANCT04121533
Vitamin D Supplementation in Knee Osteoarthritis
A study testing Vitamin D (cholecalciferol) and Glucosamine sulfate and omega-3 fatty acids in people with Osteoarthritis, Knee and Vitamin D Supplementation, run by Intermountain Health Care, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee, Vitamin D Supplementation
- What is being tested?
- Vitamin D (cholecalciferol) and Glucosamine sulfate and omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2011to 8 Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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)
About this study
Official title: The Influence of Vitamin D Supplementation With and Without Glucosamine Sulfate and Omega-3 Fatty Acids in Patients With Osteoarthritis Symptoms
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Vitamin D Supplementation
- Being tested
- Placebo, Vitamin D (cholecalciferol), Glucosamine sulfate and omega-3 fatty acids
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo supplement for vitamin D (cholecalciferol), glucosamine sulfate, and omega-3 fatty acids. Supplement was taken orally every day for 84-days.
Vitamin D (cholecalciferol)Dietary supplement
Vitamin D (cholecalciferol). Supplement was taken orally every day for 84-days.
Glucosamine sulfate and omega-3 fatty acidsDietary supplement
Glucosamine sulfate and omega-3 fatty acids supplement was taken orally every day for 84-days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements taken daily for 84 days (12 weeks). Receives: 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). Receives: 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). Receives: Dietary Supplement: Vitamin D (cholecalciferol); Dietary Supplement: Glucosamine sulfate and omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating (serum) IL-10 concentration
The influence of supplemental vitamin D on serum IL-10 concentration (pg/mL) in subjects with knee osteoarthritis.
Measured: 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.
Measured: Day 84
Secondary outcomes (1)
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.
Measured: Day 28 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start28 Jul 2011
- Primary completion8 Jan 2013
- Study completion8 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- USANA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Tyler Barker, PhD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121533
- Sponsor's protocol ID
- 1023358
- Acronym
- VitD-OA
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Vitamin D Supplementation With and Without Glucosamine Sulfate and Omega-3 Fatty Acids in Patients With Osteoarthritis Symptoms
- ClinicalTrials.gov ID
- NCT04121533
- Acronym / sponsor ID
- VitD-OA / 1023358
- Conditions
- Osteoarthritis, Knee, Vitamin D Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- USANA Health Sciences
- Study start
- 28 Jul 2011 (actual)
- Primary completion
- 8 Jan 2013 (actual)
- Study completion
- 8 Jan 2013 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements taken daily for 84 days (12 weeks). |
| Vitamin D | Experimental | Dietary Supplement: Vitamin D (cholecalciferol)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, glucosamine sulfate, and omega-3 fatty acids | Experimental | Dietary Supplement: Vitamin D (cholecalciferol), Dietary Supplement: Glucosamine sulfate and omega-3 fatty acidsVitamin 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo supplement for vitamin D (cholecalciferol), glucosamine sulfate, and omega-3 fatty acids. Supplement was taken orally every day for 84-days. | Dietary supplement | Placebo |
| Vitamin D (cholecalciferol)Vitamin D (cholecalciferol). Supplement was taken orally every day for 84-days. | Dietary supplement | Vitamin D, Vitamin D, glucosamine sulfate, and omega-3 fatty acids |
| Glucosamine sulfate and omega-3 fatty acidsGlucosamine sulfate and omega-3 fatty acids supplement was taken orally every day for 84-days. | Dietary supplement | Vitamin D, glucosamine sulfate, and omega-3 fatty acids |
Primary outcome
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.
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.
1 secondary outcome
Patient reported pain and physical dysfunction
Time frame: Day 28 and Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Barker, PhD principal investigator
Intermountain Health Care, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (cholecalciferol) and Glucosamine sulfate and omega-3 fatty acids in people with Osteoarthritis, Knee and Vitamin D Supplementation, run by Intermountain Health Care, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating (serum) IL-10 concentration (time frame: Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.