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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
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional Rickets focused on measuring Nutritional Rickets, Calcium, Vitamin D

Eligibility Criteria

6 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 12, 2012
    Last Updated
    April 17, 2012
    Sponsor
    Lady Hardinge Medical College
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    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

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