Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial.

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

The objective of this 2 × 2 factorial trial is to investigate the effect of vitamin D, n-3 LCPUFAs or a combination of both on core symptoms of ASD.

Baseline data will be used to assess and correct basic nutritional deficiencies prior to treatment allocation.

Why It Was Studied

However, there are no trials that have measured the effect of both vitamin D and n-3 LCPUFA supplementation on autism severity symptoms.

Registered on 16 February 2015.

Who Took Part

According to the abstract, 168 children were involved.

The age groups tagged for this paper are children.

All researchers, participants and their caregivers will be blinded until the data analysis is completed, and randomisation of the active/placebo capsules and allocation will be fully concealed from all mentioned parties.

How the Study Was Run

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

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

The primary outcome measures are the change in social-communicative functioning, sensory processing issues and problem behaviours between baseline and 12 months.

A secondary outcome measure is the effect on gastrointestinal symptoms.

What Was Measured

However, there are no trials that have measured the effect of both vitamin D and n-3 LCPUFA supplementation on autism severity symptoms.

PubMed files the paper under topics including Autism Spectrum Disorder, Clinical Protocols, Data Interpretation, Statistical, Dietary Supplements, Fatty Acids, Omega-3, Medication Adherence and Outcome Assessment, Health Care.

Author keywords: ASD, Omega-3 fatty acids 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 168 children.

Its findings take up roughly 2 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2016 (Trials), a journal based in England.

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