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
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
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
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: OtherTreatment
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 - 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
- MacFarlane, Lindsey A., Nancy R. Cook, Eunjung Kim, I‐Min Lee, Maura D. Iversen, David Gordon, Julie E. Buring, Jeffrey N. Katz, JoAnn E. Manson, and Karen H. Costenbader. 2020. “The Effects of Vitamin D and Marine Omega‐3 Fatty Acid Supplementation on Chronic Knee Pain in Older US Adults: Results from a Randomized Trial”. Arthritis & Rheumatology. Wiley. doi:10.1002/art.41416.
- Costenbader, Karen H, Lindsey A MacFarlane, I-Min Lee, Julie E Buring, Samia Mora, Vadim Bubes, Gregory Kotler, Carlos A Camargo Jr., JoAnn E Manson, and Nancy R Cook. 2019. “Effects of One Year of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Biomarkers of Systemic Inflammation in Older US Adults”. Clinical Chemistry. Oxford University Press (OUP). doi:10.1373/clinchem.2019.306902.
- Costenbader, Karen H, Lindsey A MacFarlane, I-Min Lee, Julie E Buring, Samia Mora, Vadim Bubes, Gregory Kotler, Carlos A Camargo Jr., JoAnn E Manson, and Nancy R Cook. 2019. “Effects of One Year of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Biomarkers of Systemic Inflammation in Older US Adults”. Clinical Chemistry. Oxford University Press (OUP). doi:10.1373/clinchem.2019.306902.
- Hahn, Jill, Nancy R Cook, Erik K Alexander, Sonia Friedman, Joseph Walter, Vadim Bubes, Gregory Kotler, I-Min Lee, JoAnn E Manson, and Karen H Costenbader. 2022. “Vitamin D and Marine Omega 3 Fatty Acid Supplementation and Incident Autoimmune Disease: VITAL Randomized Controlled Trial”. Bmj. BMJ. doi:10.1136/bmj-2021-066452.
- Hahn, Jill, Nancy R Cook, Erik K Alexander, Sonia Friedman, Joseph Walter, Vadim Bubes, Gregory Kotler, I-Min Lee, JoAnn E Manson, and Karen H Costenbader. 2022. “Vitamin D and Marine Omega 3 Fatty Acid Supplementation and Incident Autoimmune Disease: VITAL Randomized Controlled Trial”. Bmj. BMJ. doi:10.1136/bmj-2021-066452.
- Karen H. Costenbader 2010. "Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01351805.
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