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NCT01704859 · ClinicalTrials.gov registry record · NA

VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers

A NA study of Fractures, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
25,871
Enrollment target
1
Study location

NCT01704859: Completed NA study of Fractures, sponsored by Brigham and Women's Hospital.

NCT01704859 is a NA study of Fractures that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 25,871 participants, above the 9,057-participant average among 3 other Fractures trials with a reported enrollment target (186% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01704859, a NA study of Fractures, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
25,871 participants
Enrollment target
1
Study location

Study Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 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 participants in VITAL and will examine (1) whether vitamin D reduces incident total, non-vertebral fractures, and hip fractures and (2) whether this reduction is modified by vitamin D levels

Primary Outcome

To determine whether vitamin D supplementation will reduce incident total, non-vertebral, and hip fractures according to annual questionnaires, medical record review, and fracture adjudication.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Vitamin D3
  • DIETARY_SUPPLEMENT Vitamin D3 placebo
  • DIETARY_SUPPLEMENT Fish oil placebo
  • DRUG omega-3 fatty acids (fish oil)

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 25,871 participants
Start Date 2018-06-01
Est. Completion 2022-11-23
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT01704859 record still lists

NCT01704859 is an interventional study that assigns participants to a tested intervention. Its 25,871 participants enrollment target places it among the larger protocols in the corpus, above the 9,057-participant average among 3 other Fractures trials with a reported enrollment target (186% higher).

The record links to 1 condition, with Fractures appearing as the primary indexed condition, and to 4 interventions - of which Vitamin D3 is the first listed.

NCT01704859 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01704859 about?

NCT01704859 is a clinical study titled "VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers". The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 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...

What is the current status of trial NCT01704859?

This trial is currently completed. It is a NA study. The enrollment target is 25,871 participants. The study started on 2018-06-01. Estimated completion is 2022-11-23.

What conditions does trial NCT01704859 study?

This clinical trial studies the following conditions: Fractures.

What interventions are being tested in trial NCT01704859?

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

Who is sponsoring clinical trial NCT01704859?

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

Where is trial NCT01704859 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Fractures

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT01704859, the US trial registry maintained by the National Library of Medicine. NCT01704859 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.