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

NCT ID: NCT01578434

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-04-30

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.

Conditions

Nutritional Rickets

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calcium Carbonate

Calcium: 75 mg/kg calcium daily for 3 months

Group Type: ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type: DRUG

Calcium: 75 mg/kg calcium daily for 3 months

Vitamin D

Vitamin D: 6 lakh IU single im dose

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

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

Vitamin D and Calcium

vitamin D and Calcium: combination of above two

Group Type: ACTIVE_COMPARATOR

Vitamin D and Calcium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Calcium Carbonate

Calcium: 75 mg/kg calcium daily for 3 months

Intervention Type: DRUG

Vitamin D and Calcium

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Varun

Principal Investigator, Senior Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

rickets 1

Identifier Type: -

Identifier Source: org_study_id