Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
ROCAVINR
1 other identifier
interventional
67
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedApril 19, 2012
April 1, 2012
1.3 years
April 12, 2012
April 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Healing of rickets
Assessment of healing of rickets on biochemical and radiological assessment
6 months
Study Arms (3)
Calcium Carbonate
ACTIVE COMPARATORCalcium: 75 mg/kg calcium daily for 3 months
Vitamin D
ACTIVE COMPARATORVitamin D: 6 lakh IU single im dose
Vitamin D and Calcium
ACTIVE COMPARATORvitamin D and Calcium: combination of above two
Interventions
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
Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months
Eligibility Criteria
You may qualify if:
- children aged 6 months to 5 years with rickets
You may not qualify if:
- Non nutritional cause of rickets
- taken vitamin D or calcium supplements in last 6 months
- children presenting with convulsions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Senior Resident Physician
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 17, 2012
Study Start
November 1, 2007
Primary Completion
February 1, 2009
Study Completion
April 1, 2009
Last Updated
April 19, 2012
Record last verified: 2012-04