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Studying vitamin D status and the efficacy of vitamin D supplementation in autistic children in Bangladesh

Studying vitamin D status in autism spectrum disorder and the efficacy of vitamin D supplementation in autistic children in Bangladesh

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030101
Enrollment
120
Registered
2020-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: - Health Condition 2: F949- Childhood disorder of social functioning, unspecified

Interventions

Intervention1: Vitamin D: Vitamin D capsule 800 IU will daily given to children for 6 months Control Intervention1: Nil: Nil

Sponsors

BANBEIS Ministry of Education
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ) Autistic children with 25(OH)D deficiency ( iv) Children having no significant hearing or vision loss. v) Children having no other neurological disorders, e.g., cerebral palsy, phenylketonuria, tuberous sclerosis, neurofibromatosis, and seizure disorders. vi) Children having no history of severe head trauma or stroke. vii) Children having no feeding problems or malnutrition. viii) Children having no genetic disorders (i.e., Down syndrome, fragile x, Rett syndrome). ix) Children having no Prematurity or postmaturity. x) Subjects are not associated with gastrointestinal problems, autoimmune disorders, and anemia. xi) Children with no known endocrine, cardiovascular, pulmonary, liver or kidney disease, clinically active infection, morbid obesity, cancer. xii) Participants at present or within the preceding 2 months before the study are not taking the following medications or supplements: cod liver oil, vitamin A, Vitamin D, minarels, steroids, thiazide diuretics, digoxin, diltiazem, verapamil, cimetidine, heparin. xii) Children having no relevant interaction of prescribed vitamin D with concurrent medication or contraindications. xiii) Children having no hypersensitivity reactions to vitamin D.

Exclusion criteria

Exclusion criteria: Age: below 2 years and above 15 years. ii) Children with normal serum 25(OH)D level (above 30 ng/ml). iii) Children having significant hearing or vision loss. iv) Children having other neurological disorders, e.g., cerebral palsy, phenylketonuria, tuberous sclerosis, neurofibromatosis, and seizure disorders. v) Children having history of severe head trauma or stroke. v) Children having feeding problems or malnutrition. vi) Children having genetic disorders (i.e., Down syndrome, fragile x, Rett syndrome). vii) Children having prematurity or post maturity. viii) Subjects are associated with gastrointestinal problems, autoimmune disorders, and anemia. ix) Children with known endocrine, cardiovascular, pulmonary, liver or kidney disease, clinically active infection, morbid obesity, cancer. x) Participants at present or within the preceding 2 months before the study are taking the following medications or supplements: cod liver oil, vitamin A, Vitamin D, minarels, steroids, thiazide diuretics, digoxin, diltiazem, verapamil, cimetidine, heparin. xi) Children having relevant interactions of prescribed vitamin D with concurrent medication or contraindications. xii) Children having hypersensitivity reactions to vitamin D.

Design outcomes

Primary

MeasureTime frame
Parameters: 1. DSM 5 Diagnostic Criteria for ASD scores 2. Adverse event due to supplementation of Vitamin DTimepoint: Baseline (Day 0) to complete recovery

Secondary

MeasureTime frame
1. Increased serum vitamin levels (ng/ml) levels towards normalTimepoint: Day 0, 90, 180

Countries

Bangladesh

Contacts

Public ContactAbu Syed Md Mosaddek

Uttara Adhunik Medical College

Drmosaddek1968@gmail.com01711483814

Outcome results

None listed

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