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NCT01633177 · ClinicalTrials.gov registry record · Phase 3

Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes

A Phase 3 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 3
Development phase
22,220
Enrollment target

NCT01633177 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 22,220 participants.

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The verdict

NCT01633177, a Phase 3 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 3
Development phase
22,220 participants
Enrollment target

Study Summary

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 dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among nondiabetic participants in VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from this ancillary study (n=22220 without diabetes at baseline) conducted within the VITAL trial will clarify whether vitamin D and omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform public health and clinical guidelines for diabetes prevention.

Interventions

  • DIETARY_SUPPLEMENT Vitamin D3
  • DIETARY_SUPPLEMENT Vitamin D3 placebo
  • DRUG Fish oil placebo
  • DRUG Omega-3 fatty acid (fish oil)

Trial Details

FieldValue
Enrollment Target 22,220 participants
Start Date 2011-11
Est. Completion 2024-05-30
Phase Phase 3

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT01633177

The ClinicalTrials.gov registry entry for NCT01633177 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 22,220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Vitamin D3 is the first listed.

NCT01633177 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01633177 about?

NCT01633177 is a clinical study titled "Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes". 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 dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart dis...

What is the current status of trial NCT01633177?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 22,220 participants. The study started on 2011-11. Estimated completion is 2024-05-30.

What interventions are being tested in trial NCT01633177?

The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT), Vitamin D3 placebo (DIETARY_SUPPLEMENT), Fish oil placebo (DRUG), Omega-3 fatty acid (fish oil) (DRUG).

Who is sponsoring clinical trial NCT01633177?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.