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

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ClinicalTrials.gov Identifier: NCT01578434
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):
Varun, Lady Hardinge Medical College

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.

Condition or disease Intervention/treatment Phase
Nutritional Rickets Drug: Vitamin D Drug: Calcium Carbonate Drug: Vitamin D and Calcium Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Study Start Date : November 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Healing of rickets [ Time Frame: 6 months ]
    Assessment of healing of rickets on biochemical and radiological assessment



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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

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
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by Varun, Lady Hardinge Medical College:
Nutritional Rickets
Calcium
Vitamin D

Additional relevant MeSH terms:
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents