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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Autism

Treatments: Drug: Vitamin D3; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02550912

PhD(NO.18)

Details and patient eligibility

About

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

Full description

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

Enrollment: 42 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

42 participants in 2 patient groups, including a placebo group

Vitamin D group

Active Comparator group

Description:

Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months.

Treatment:

Drug: Vitamin D3

Placebo group

Placebo Comparator group

Description:

Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.

Treatment:

Other: Placebo