Study on supplementing children with abnormal body movements with a oral Vitami
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Children with epilepsy on anti-epileptic drug therapy
- Registration Number
- CTRI/2017/08/009234
- Lead Sponsor
- ady Hardinge Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Children of 5 - 10 years
2. Started on anti epileptic drug therapy within the past 2 weeks of presenting to the OPD / Epilepsy clinic or fresh cases of seizures started on anti epileptic drugs in the hospital
3. Started on or receiving either or combined phenytoin, valproate, carbamazepine, phenobarbitone or other newer anti-epileptic drugs
4. Normal nutritional status - BMI within +/- 2 Z scores of WHO standards
Exclusion Criteria
1. Children on calcium or vitamin D supplements currently or receiving it in the last 6 months
2. Clinical or biochemical evidence of rickets
3. Any chronic illness that can influence vitamin D metabolism ( chronic liver disease, chronic kidney disease and malabsorption states)
4. Non ambulatory patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of supplementation with 60,000 IU of vitamin D per month for a period of 6 months on the serum levels of 25 hydroxy Vitamin D {25 (OH) D} in pre-pubertal children freshly started on anti-epileptic drug medicationsTimepoint: To assess the effect of supplementation with 60,000 IU of vitamin D per month for a period of 6 months on the serum levels of 25 hydroxy Vitamin D {25 (OH) D} in pre-pubertal children freshly started on anti-epileptic drug medications
- Secondary Outcome Measures
Name Time Method To compare the indicators of bone turn over - serum calcium, serum Alkaline phosphatase, serum parathyroid hormone and serum inorganic phosphate in supplemented children as compared to those not similarly supplementedTimepoint: 6 months