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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varun, Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01578434
First received: April 12, 2012
Last updated: April 17, 2012
Last verified: April 2012
  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:

  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.

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

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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 August 20, 2014