Vitamin D + Fish Oil for Anemia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cancer, Heart disease, Stroke, Anemia

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily supplements of vitamin D3 or omega-3 fish oil can reduce the risk of developing anemia, a condition characterized by insufficient healthy red blood cells. Researchers will examine if these supplements help with anemia and monitor changes in blood proteins over time. The trial includes participants from a larger study who reported anemia on follow-up questionnaires. Participants in the VITAL study who have been diagnosed with anemia might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding potential new methods for managing anemia.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both vitamin D3 and omega-3 fatty acids are usually safe for daily use. In past studies, participants experienced very few side effects from these supplements. Occasionally, vitamin D3 may cause mild issues like an upset stomach or headache. Omega-3 fatty acids, often taken as fish oil, can sometimes leave a fishy taste or cause mild digestive problems, but these are generally not serious.

These supplements are widely used and have been thoroughly studied. The FDA has already approved them for other purposes, indicating they are safe for most people. However, if specific health concerns exist or other medications are being taken, consulting a doctor before starting any new supplement is always wise. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Vitamin D and marine omega-3 fatty acids to tackle anemia because these nutrients offer a natural and potentially less invasive alternative to traditional treatments like iron supplements and erythropoietin-stimulating agents. Vitamin D3 and omega-3 fatty acids may help improve blood health by supporting the body’s natural processes, such as enhancing iron absorption and reducing inflammation, which are not the primary focus of typical anemia treatments. This approach not only aims to address the root causes of anemia but also provides additional health benefits like improved heart and bone health, setting it apart from conventional options.

What evidence suggests that this trial's treatments could be effective for reducing the risk of cancer, heart disease, and stroke?

Research has shown that omega-3 fatty acids can help lower triglyceride levels in the blood, potentially benefiting heart health. Some studies suggest they are effective alone or in combination with other treatments. Vitamin D3 has shown potential in reducing the risk of dying from cancer, though it may not prevent cancer itself. It might also help protect DNA over time, possibly slowing aging. In this trial, participants will receive either a combination of omega-3 fatty acids and Vitamin D3 or placebos for one or both supplements. However, the VITAL trial found that taking 1 gram of omega-3 or 2000 IU of vitamin D3 daily did not significantly lower the risk of major health issues like heart disease, cancer, or stroke. ^{6 7 8 9 10}

Who Is on the Research Team?

Nancy Berliner, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for participants of the VITAL study who don't have anemia at the start but later report a diagnosis of anemia. It's focused on U.S. men and women without prior cancer, heart disease, or stroke.

Inclusion Criteria

I was in the VITAL study, didn't have anemia at first but reported anemia later.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily dietary supplements of vitamin D3 or omega-3 fatty acids, or their placebos, for primary prevention of cancer and cardiovascular disease.

2 years

Annual questionnaire and occasional phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples collected at baseline and two years later to assess long-term changes in blood protein levels.

2 years

Blood samples at baseline and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 Fatty Acids
• Vitamin D3

Trial Overview The trial tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of developing anemia. It also examines blood protein changes over two years in a Boston subcohort.

How Is the Trial Designed?

Group I: Vitamin D + fish oil Active Control 2 Interventions

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Drug: omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group II: Vitamin D + fish oil placebo Active Control 2 Interventions

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Dietary Supplement: Fish oil placebo Fish oil placebo

Group III: Vitamin D placebo + fish oil placebo Active Control 2 Interventions

Dietary Supplement:Vitamin D3 placebo Vitamin D placebo Dietary Supplement: Fish oil placebo Fish oil placebo

Group IV: Vitamin D placebo + fish oil Active Control 2 Interventions

Drug: omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]). Dietary Supplement: Vitamin D3 placebo Vitamin D placebo

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Office of Dietary Supplements (ODS)

Collaborator

Trials

55

Recruited

54,500+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5383544/

A Randomized, Double-Blind, Placebo-Controlled Clinical ... Several placebo-controlled studies have reported the efficacy of omega-3 fatty acids concentrates in lowering triglyceride in patients with moderately-elevated ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16919519/

Clinical overview of Omacor: a concentrated formulation ... At a typical dose of 4 capsules/day, Omacor significantly lowers plasma triglyceride levels either as monotherapy or in combination with 3-hydroxy-3- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914905021922

Clinical Overview of Omacor: A Concentrated Formulation ... At a typical dose of 4 capsules/day, Omacor significantly lowers plasma triglyceride levels either as monotherapy or in combination with 3-hydroxy-3- ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000709

Omega-3 Fatty Acids for the Management of ... Effects of a fish oil ... A double-blind randomized trial of fish oil to lower triglycerides and improve cardiometabolic risk in adolescents.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf

OMACOR® Omega-3-acid ethyl esters, capsules Omacor® may reduce the synthesis of triglycerides (TGs) in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01758081

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious ... The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25864623/

Update on the Vitamin D and OmegA-3 trial (VITAL) - PubMed The VITamin D and OmegA-3 TriaL (VITAL) is a 2×2 factorial randomized, double-blind, placebo-controlled trial of the benefits and risks of vitamin D (vitamin D3 ...

8. aao.org aao.org/eyenet/article/vitamin-d3-omega-3-fatty-acids-and-amd-risk

Vitamin D3, Omega-3 Fatty Acids, and AMD Risk Christen et al. explored the effect of daily supplementation with vitamin D3 and marine omega-3 fatty acids on the risk and progression of age-related macular ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01169259

NCT01169259 | Vitamin D and Omega-3 Trial (VITAL) The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements ...

10. brighamandwomens.org brighamandwomens.org/medicine/endocrinology-diabetes-and-hypertension/advances-newsletters/vitamin-d-and-omega-3-vital-clinical-trial

VITAL: The VITamin D and OmegA-3 TriaL VITAL is a randomized, double-blind, placebo-controlled trial of Vitamin D and omega-3 fatty acids that is following a multiethnic population for five years.