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Effect of vitamin D3 in autism children

Efficacy of Vitamin D3 in the management of mild to moderate autistic children - A Randomized controlled trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061228
Enrollment
100
Registered
2024-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: F988- Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence

Interventions

Intervention1: Vitamin D3: Dose: 60000 IU
Frequency: 2 weeks once
Duration: 2 months Control Intervention1: Occupational therapy + Speech therapy: Dose: NA
Frequency: 3 times a week
Route of administration: NA
Duration: 2 months

Sponsors

SRM Institute of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mild-to-moderate ASD children diagnosed using Childhood Autism Rating Scale, Second Edition-Standard Version (CARS2-ST) 2. Parents who are willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Children undergoing any chronic drug treatment 2. Severe intellectual disability 3. History of seizure 4. Presence of hepatic disease 5. Having any other genetic and chromosomal syndromes • Children with chronic illness or known hormonal and metabolic diseases • Parents will be informed not to change the number of hours and frequency of sessions of occupational and speech therapy during the study period. Parents will also be informed not to change routine food habits during the study period. If the research team identify any violation of these, they will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
change in vitamin D3 levels between baseline and at the end of 3 months.Timepoint: 3 months

Secondary

MeasureTime frame
change in the scores of CARS2-ST, Autism Treatment Evaluation Checklist (ATEC), BEARS sleep screening tool and 6-item Gastrointestinal Severity Index (6-GSI) between baseline and at the end of 3 months.Timepoint: 3 months

Countries

India

Contacts

Public ContactDR MG Rajanandh

SRM Institute of Science and Technology

surmbbs@gmail.com9940403011

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026