Role of Calcium And Vitamin D In Nutritional Rickets And It's Management (ROCAVINR)
Primary Purpose
Nutritional Rickets
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vitamin D
Calcium Carbonate
Vitamin D and Calcium
Sponsored by
About this trial
This is an interventional treatment trial for Nutritional Rickets focused on measuring Nutritional Rickets, Calcium, Vitamin D
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Calcium Carbonate
Vitamin D
Vitamin D and Calcium
Arm Description
Calcium: 75 mg/kg calcium daily for 3 months
Vitamin D: 6 lakh IU single im dose
vitamin D and Calcium: combination of above two
Outcomes
Primary Outcome Measures
Healing of rickets
Assessment of healing of rickets on biochemical and radiological assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT01578434
First Posted
April 12, 2012
Last Updated
April 17, 2012
Sponsor
Lady Hardinge Medical College
1. Study Identification
Unique Protocol Identification Number
NCT01578434
Brief Title
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Acronym
ROCAVINR
Official Title
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Rickets
Keywords
Nutritional Rickets, Calcium, Vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium Carbonate
Arm Type
Active Comparator
Arm Description
Calcium: 75 mg/kg calcium daily for 3 months
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D: 6 lakh IU single im dose
Arm Title
Vitamin D and Calcium
Arm Type
Active Comparator
Arm Description
vitamin D and Calcium: combination of above two
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
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
Intervention Name(s)
Calcium Carbonate
Intervention Description
Calcium: 75 mg/kg calcium daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Vitamin D and Calcium
Intervention Description
Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months
Primary Outcome Measure Information:
Title
Healing of rickets
Description
Assessment of healing of rickets on biochemical and radiological assessment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
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