VITAL-Bone Health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA-3 TriaL (VITAL).

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a randomized controlled trial.

Results from large, randomized controlled trials in the general population are sparse.

Data on the effects of supplemental omega-3 fatty acids (FAs) on bone are also limited.

Who Took Part

According to the abstract, 50 women were involved.

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

To comprehensively test effects of supplemental vitamin D and/or omega-3 FAs on skeletal health, the VITAL: Effects on Fractures ancillary study is determining the effects of these supplements on incident fractures among 25,875 participants enrolled in the parent trial.

In a complementary ancillary, VITAL: Effects on Structure and Architecture is determining the effects of supplemental vitamin D and/or omega-3 FAs on bone with detailed phenotyping during in-person visits.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Neither the women nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Vitamin D, K2, Magnesium and Zinc group a baseline to be compared against.

Study investigators adjudicate fractures through a detailed review of medical records and radiological images (hip and femur).

Comprehensive assessments of bone density, turnover, structure/architecture, body composition, and physical performance are being performed at baseline and 2 years post-randomization.

What Was Measured

The subject headings attached to it are Absorptiometry, Photon, Bone Density, Bone Density Conservation Agents, Cholecalciferol, Dietary Supplements, Fatty Acids, Omega-3 and Femur.

The authors tagged it with the keywords Bone mineral density, Bone turnover, Fractures, Omega-3 fatty acids, Trabecular bone score and Vitamin D.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 50 women.

Its findings take up roughly 1 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2015 (Contemporary clinical trials), a journal based in United States.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.