MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

In this study the researchers aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented.

Why It Was Studied

MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR.

Osteoporosis is a major public health problem as a result of associated fragility fractures.

Who Took Part

By PubMed's age tags, the people studied were infants and young children, women only.

Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford).

The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Some participants received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption.

At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry.

At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue.

Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years.

What Was Measured

The subject headings attached to it are Absorptiometry, Photon, Age Factors, Biomarkers, Bone Density, Bone and Bones, Cholecalciferol and Dietary Supplements.

What This Means in Plain Language

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

The abstract goes on to report its results in about 2 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2012 (Trials), a journal based in England.

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