Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Other: Placebo; Drug: Vitamin D and fish oil; Drug: Vitamin D alone; Dietary Supplement: Fish oil (EPA/DHA) alone

Study type: Interventional

Funder types: Other

Identifiers

NCT02271230

2014P001206

Details and patient eligibility

About

This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.

Full description

For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.

Enrollment: 25,871 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men aged 50 or older or women aged 55 or older
• Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
• Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
• Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial

Exclusion criteria

• prevalent heart failure
• History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI
• History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
• Allergy to fish or soy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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25,871 participants in 4 patient groups, including a placebo group

Vitamin D and fish oil

Experimental group

Description:

2000 IU per day and 1 g per day of fish oil

Treatment:

Drug: Vitamin D and fish oil

Vitamin D alone

Placebo Comparator group

Description:

2000 IU Vitamin D and fish oil placebo

Treatment:

Drug: Vitamin D alone

Fish oil (EPA/DHA) alone

Experimental group

Description:

1 g per day of fish oil and vitamin D placebo

Treatment:

Dietary Supplement: Fish oil (EPA/DHA) alone

Fish oil and vitamin D placebo

Placebo Comparator group

Description:

Placebo for both vitamin D and fish oil

Treatment:

Other: Placebo