Health Condition 1: E550- Rickets, active
Conditions
Interventions
Intervention1: Vitamin D3: Liquid preparation with daily dosage of 2000 IU for 12 weeks
Control Intervention1: Vitamin D3: Stoss therapy- 60,000 IU weekly administered for 3 or 6 weeks (total dose as
Sponsors
Maulana Azad Medical College and Lok Nayak Hospital and GIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of nutritional rickets defined by clinical, biochemical and radiological parameters. 2. Residence within 50 km of hospital who are willing for follow up visits
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed or suspected diagnosis of malabsorption or chronic kidney or hepatic disease. 2. Patients with severe systemic illness compromising oral intake (tachycardia, tachypnea, shock, weak peripheral pulses, increased capillary refill time). 3. Patients who have taken calcium supplements or vitamin D preparation in last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children who will achieve complete radiological healing (defined as radiological score â?¤ 1.5) at 12 weeks across three regimes Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Increase in serum 25(OH) D3 at 12 weeks 2) Decline in PTH level at 12 weeks 3) Decline in ALP level at 12 weeks. 4) Proportion of children with severe vitamin D deficiency (serum 25OHD less than 12ng/mL) Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactAashima Dabas
Maulana Azad Medical College
Outcome results
None listed