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

Study Overview
=================
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: To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.

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

Conditions
-----------------
Nutritional Rickets

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Calcium Carbonate
* Drug: Vitamin D and Calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium Carbonate<br>Calcium: 75 mg/kg calcium daily for 3 months | Drug: Calcium Carbonate<br>* Calcium: 75 mg/kg calcium daily for 3 months<br>|
| Active Comparator: Vitamin D<br>Vitamin D: 6 lakh IU single im dose | Drug: Vitamin D<br>* Vitamin D: 6 lakh IU single im dose Calcium: 75 mg/kg calcium daily for 3 months vitamin D and Calcium: combination of above two<br>|
| Active Comparator: Vitamin D and Calcium<br>vitamin D and Calcium: combination of above two | Drug: Vitamin D and Calcium<br>* Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of rickets | Assessment of healing of rickets on biochemical and radiological assessment | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Nutritional Rickets, Calcium