Vitamin D for Inflammation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Inflammation+7 More
Vitamin D - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether taking daily dietary supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

Eligible Conditions
  • Inflammation
  • Knee
  • Systemic Inflammatory Process
  • Rheumatoid Arthritis
  • Autoimmune Diseases
  • Arthrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: extension of follow-up through 7 years post trial closure

5 years
Autoimmune Diseases
Year 5
Interactions Between the Effects of Vitamin D and Those of Fish Oils for Each of the . Reported With Main Results.
Subgroup Analysis of . Reported With Main Results, .
Baseline and 1 year
Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)
Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)
Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2)
Baseline and 5 years
Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With Vitamin D
Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA
Ergocalciferol
Year 7
Incident Autoimmune Disease

Trial Safety

Safety Progress

1 of 3

Side Effects for

Risedronate
12%Back pain
7%Arthralgia
3%Fall
1%Osteoarthritis
1%Humerus fracture
1%Hip fracture
1%Femur fracture
1%Lumbar vertebral fracture
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01709110) in the Risedronate ARM group. Side effects include: Back pain with 12%, Arthralgia with 7%, Fall with 3%, Osteoarthritis with 1%, Humerus fracture with 1%.

Trial Design

4 Treatment Groups

Fish Oil
1 of 4
Vitamin D
1 of 4
Vitamin D and Fish Oil
1 of 4
placebo
1 of 4

Experimental Treatment

Non-Treatment Group

25871 Total Participants · 4 Treatment Groups

Primary Treatment: Vitamin D · Has Placebo Group · N/A

Fish OilExperimental Group · 2 Interventions: Fish Oil, placebo pill · Intervention Types: Drug, Other
Vitamin DExperimental Group · 2 Interventions: Vitamin D, placebo pill · Intervention Types: DietarySupplement, Other
Vitamin D and Fish OilExperimental Group · 2 Interventions: Fish Oil, Vitamin D · Intervention Types: Drug, DietarySupplement
placebo
Other
PlaceboComparator Group · 1 Intervention: placebo pill · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acids
FDA approved
Vitamin D
2013
Completed Phase 4
~3470

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: extension of follow-up through 7 years post trial closure

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
446 Previous Clinical Trials
1,045,561 Total Patients Enrolled
3 Trials studying Inflammation
1,045 Patients Enrolled for Inflammation
Brigham and Women's HospitalLead Sponsor
1,472 Previous Clinical Trials
9,709,394 Total Patients Enrolled
13 Trials studying Inflammation
23,497 Patients Enrolled for Inflammation
Karen H Costenbader, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References