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

Phase 4
Conditions
Health Condition 1: - Health Condition 2: F949- Childhood disorder of social functioning, unspecified
Registration Number
CTRI/2020/12/030101
Lead Sponsor
BANBEIS Ministry of Education
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Applicable
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

) Autistic children with 25(OH)D deficiency ( <20 ng/ml).

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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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