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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Electroencephalography | Study protocol

Effect of vitamin D supplementation on brain waves, behavioral performance, nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in children with attention deficit/hyperactivity disorder: study protocol for a randomized clinical trial

Authors: Abbas Ali Sangouni, Hamid Mirhosseini, Mahdieh Hosseinzadeh

Published in: Trials | Issue 1/2022

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Abstract

Background

Attention deficit/hyperactivity disorder (ADHD) is the most common chronic mental and behavioral disorder among children. Some studies showed the lower levels of vitamin D in patients with ADHD compared with the healthy people. Few clinical trials were conducted in this field. The present study will be performed to examine the effect of vitamin D supplementation in children with ADHD.

Methods

We will conduct a double-blind, randomized controlled clinical trial to investigate the effect of vitamin D supplementation on brain waves, behavioral performance, serum nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in 50 patients with ADHD. The intervention group will receive one capsule 50,000 IU vitamin D every week, for 8 weeks. The control group will receive one placebo capsule containing 1000 mg olive oil every week. Electroencephalography will be performed for 10 min using Brain Master Discovery from 19 scalp sites both before the first intervention and the 10 sessions of the therapy. The artifact-free periods of 1-min electroencephalography data will be analyzed for quantitative electroencephalography measures.

Discussion

For the first time, this clinical trial will evaluate the effect of vitamin D supplementation on brain waves, serum nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in patients with ADHD. The results of the present clinical trial will provide a better vision about the vitamin D efficacy in patients with ADHD.

Trial registration

Registered on 5 November 2020 at Iranian Registry of Clinical Trials with code number IRCT20200922048802N1 (https://​www.​irct.​ir/​trial/​51410).
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Metadata
Title
Effect of vitamin D supplementation on brain waves, behavioral performance, nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in children with attention deficit/hyperactivity disorder: study protocol for a randomized clinical trial
Authors
Abbas Ali Sangouni
Hamid Mirhosseini
Mahdieh Hosseinzadeh
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06837-1

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