Health Condition 1: E550- Rickets, active
Conditions
Interventions
Intervention1: Oral vitamin D Syrup: Oral syrup in dose 2000 IU daily for 12 weeks
Control Intervention1: Oral vitamin D syrup: Oral syrup in dose 3000 IU daily for 12 weeks
Control Intervention2: Ora
Sponsors
Society of endocrine healthcare of elderly, adolescents and children
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 12-60 months with a diagnosis of nutritional rickets defined by clinical, biochemical and radiological parameters (radiology severity score =2.5).
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 supra-physiological dose of vitamin D (more than 800 IU/day) in last 6 months. 4. Children with hypercalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children who achieve complete radiological healing (defined as radiological score = 1.5)Timepoint: Baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Increase in serum 25(OH) D, 1,25(OH)D at 12 weeks 2) Decline in PTH and CTX level at 12 weeks 3) Decline in ALP level at 12 weeks. 4) Proportion of children with severe vitamin D deficiency (serum 25OHD 12ng/mL)Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactAashima Dabas
Maulana Azad Medical College
Outcome results
None listed