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

Nutritional Rickets Clinical Trial

— ROCAVINR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578434
• Other study ID #: rickets 1
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2012
• Last updated: April 17, 2012
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2012
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nutritional Rickets
• Rickets

Intervention

Drug:
• Vitamin D
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
• Calcium Carbonate
Calcium: 75 mg/kg calcium daily for 3 months
• Vitamin D and Calcium
Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of rickets	Assessment of healing of rickets on biochemical and radiological assessment	6 months	No