A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children

A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02550912

Enrollment

Registered

2015-09-16

Start date

2015-08-31

Completion date

2016-03-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Brief summary

The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.

Detailed description

Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.

Interventions

DRUGVitamin D3

vitamin D drops for paediatrics

OTHERPlacebo

glucose syrup with same taste and color to vitamin D3 drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism

Exclusion criteria

* Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.

Design outcomes

Primary

Measure	Time frame
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)	At baseline, 12 weeks ,24 weeks
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)	At baseline, 12 weeks ,24 weeks

Secondary

Measure	Time frame
Effect of vitamin D on alkaline phosphatase level	At baseline,12 weeks ,24 weeks
Effect of vitamin D on parathyroid hormone level	At baseline,12 weeks ,24 weeks
Effect of vitamin D on calcium level	At baseline, 12 weeks ,24 weeks
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)	At baseline, 12 weeks ,24 weeks
Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)	At baseline, 12 weeks ,24 weeks
Effect of vitamin D on phosphorous level	At baseline, 12 weeks ,24 weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026