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The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.
Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Active Comparator | 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. |
|
| Placebo group | Placebo Comparator | Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | vitamin D drops for paediatrics |
|
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of vitamin D on calcium level | At baseline, 12 weeks ,24 weeks | |
| Effect of vitamin D on phosphorous level | At baseline, 12 weeks ,24 weeks | |
| Effect of vitamin D on alkaline phosphatase level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sarah f mohamed fahmy, masters | assistant lecturer clinical pharmacy ainshams university | Principal Investigator |
| nagwa A sabri, professor | professor in clinical pharmacy Ainshams university | Study Director |
| manal H elhamamsy, professor | professor in clinical pharmacy Ainshams university | Study Director |
| mohamed A elsawi, professor | professor in pediatrics and genetics ainshams university | Study Director |
| osama k zaki, consultant | medical consultant in paediatrics and genetics unit ainshams university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy AinShams University | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D066248 | High Fructose Corn Syrup |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Other | glucose syrup with same taste and color to vitamin D3 drops |
|
|
| 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 liver function test (alanine transaminase and aspartate transaminase) | 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 |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000073417 | Dietary Sugars |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D064427 | Nutritive Sweeteners |
| D013549 | Sweetening Agents |
| D005421 | Flavoring Agents |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |