Role of Calcium And Vitamin D In Nutritional Rickets And It's Management (ROCAVINR)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nutritional Rickets |
Drug: Vitamin D Drug: Calcium Carbonate Drug: Vitamin D and Calcium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Role of Calcium And Vitamin D In Nutritional Rickets And It's Management |
- Healing of rickets [ Time Frame: 6 months ] [ Designated as safety issue: No ]Assessment of healing of rickets on biochemical and radiological assessment
| Enrollment: | 67 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Calcium Carbonate
Calcium: 75 mg/kg calcium daily for 3 months
|
Drug: Calcium Carbonate
Calcium: 75 mg/kg calcium daily for 3 months
|
|
Active Comparator: Vitamin D
Vitamin D: 6 lakh IU single im dose
|
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
|
|
Active Comparator: Vitamin D and Calcium
vitamin D and Calcium: combination of above two
|
Drug: Vitamin D and Calcium
Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months
|
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Varun, Principal Investigator, Senior Resident Physician, Lady Hardinge Medical College |
| ClinicalTrials.gov Identifier: | NCT01578434 History of Changes |
| Other Study ID Numbers: | rickets 1 |
| Study First Received: | April 12, 2012 |
| Last Updated: | April 17, 2012 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Lady Hardinge Medical College:
|
Nutritional Rickets Calcium Vitamin D |
Additional relevant MeSH terms:
|
Rickets Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Calcium Metabolism Disorders Metabolic Diseases Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Calcium, Dietary |
Vitamin D Ergocalciferols Calcium Carbonate Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013