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Effect of micronutrient supplement on health and nutritional status of schoolchildren: study design.

Plain-language guide to PMID 16426958 (2006): double-blind randomized controlled trial of Micronutrients in 869 children.

Key Facts

PMID
16426958
Journal
Nutrition (Burbank, Los Angeles County, Calif.)
Year
2006
Study type
Randomized Controlled Trial
Authors
Sivakumar B et al. (9 authors)
DOI
10.1016/j.nut.2005.07.009

What This Study Did, in Plain Language

What Was Tested

This randomized controlled trial looks at Micronutrients.

Who Took Part

The abstract describes 869 children taking part.

The age groups tagged for this paper are children and teenagers, both men and women.

The study was carried out in middle-income students in two residential schools that catered to children from a semi-urban population near Hyderabad, India.

Included were 869 children who were 6 to 16 y of age in grades 1 to 10.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Micronutrients and who got the comparison, which limits bias.

As a double-blind Micronutrients study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Micronutrients could be set against what happens without it.

Because children at each grade were distributed across two classrooms (clusters) and were homogeneous, each grade was considered to consist of a matched pair.

There were thus 10 pairs available for the study.

Classes in each grade were randomized to receive a micronutrient-enriched beverage or a placebo without added micronutrients.

The study was double blinded and the duration was 14 mo, with supervised feeding of the micronutrient-enriched beverage.

The effect of the micronutrients on the outcome variables growth, biochemical status, mental function, and bone health were assessed.

What Was Measured

Topics PubMed links to this paper include Anthropometry, Bone Development, Bone and Bones, Cluster Analysis, Cognition, Food, Fortified and Health Status.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Micronutrients in 869 children.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2006 (Nutrition (Burbank, Los Angeles County, Calif.)), a journal based in United States.

More context: all human trials.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.