Role of Calcium And Vitamin D In Nutritional Rickets And It's Management

Phase 4

Completed

• Conditions: Nutritional Rickets
• Interventions: Drug: Vitamin D and Calcium; Drug: Calcium Carbonate; Drug: Vitamin D

• Registration Number: NCT01578434
• Lead Sponsor: Lady Hardinge Medical College

Brief Summary

Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.

However, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.

Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.

The present study is therefore planned with the following objectives:

1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.

2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Status Verified: 2012-04
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• children aged 6 months to 5 years with rickets

Exclusion Criteria

• Non nutritional cause of rickets
• taken vitamin D or calcium supplements in last 6 months
• children presenting with convulsions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D and Calcium	Vitamin D and Calcium	vitamin D and Calcium: combination of above two
Calcium Carbonate	Calcium Carbonate	Calcium: 75 mg/kg calcium daily for 3 months
Vitamin D	Vitamin D	Vitamin D: 6 lakh IU single im dose

Primary Outcome Measures

Name	Time	Method
Healing of rickets	6 months	Assessment of healing of rickets on biochemical and radiological assessment