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

Lady Hardinge Medical College

Status and phase: Completed; Phase 4

Conditions: Nutritional Rickets

Treatments: Drug: Vitamin D; Drug: Vitamin D and Calcium; Drug: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01578434

rickets 1

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 3 patient groups

Calcium Carbonate

Active Comparator group

Description:

Calcium: 75 mg/kg calcium daily for 3 months

Treatment:

Drug: Calcium Carbonate

Vitamin D

Active Comparator group

Description:

Vitamin D: 6 lakh IU single im dose

Treatment:

Drug: Vitamin D

Vitamin D and Calcium

Active Comparator group

Description:

vitamin D and Calcium: combination of above two

Treatment:

Drug: Vitamin D and Calcium