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Study on supplementing children with abnormal body movements with a oral Vitamin

Effect of high dose Vitamin D supplementation on Vitamin D status of pre-pubertal children on anti-epileptic drugs - A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009234
Enrollment
80
Registered
2017-08-02
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: null- Children with epilepsy on anti-epileptic drug therapy

Interventions

Intervention1: Oral high dose Vitamin D 60,000 IU per month: Monthly oral doses of 60,000 IU of Vitamin D was given for 6 doses Control Intervention1: No intervention done: No intervention done

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactAnju Seth

Lady Hardinge Medical College

anju_seth@yahoo.com

Outcome results

None listed

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