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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01578434
Acronym
ROCAVINR
Enrollment
67
Registered
2012-04-17
Start date
2007-11-30
Completion date
2009-04-30
Last updated
2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Rickets

Keywords

Nutritional Rickets, Calcium, Vitamin D

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.

Interventions

DRUGVitamin 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

DRUGCalcium Carbonate

Calcium: 75 mg/kg calcium daily for 3 months

Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months

Sponsors

Lady Hardinge Medical College
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Healing of rickets6 monthsAssessment of healing of rickets on biochemical and radiological assessment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026