CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 109 enrolled
Drug / intervention
Vitamin D + Calcium +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00949832
NCT00949832Phase 4Completed

Vitamin D and Genetics in Nutritional Rickets

Mayo Clinic·interventional·Posted Jul 30, 2009·Updated Jul 4, 2012

In Brief

A Phase 4 clinical trial evaluating Vitamin D + Calcium, Calcium, and 2 other interventions for Nutritional Rickets. Completed, enrolled 109 participants across 1 site.

Detailed Summary

The purpose of this study is: 1. To compare the response of rickets to calcium with and without vitamin D. 2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets. 3. To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2 4. To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh. 5. To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNigeria

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2009
Enrollment StartJan 1, 2004
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.9 years ago

Interventions

Vitamin D + Calciumdietary

Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months

Calciumdietary

Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months; Vitamin B complex (used as placebo) 1 tablet monthly for 6 months

Vitamin D2dietary

50,000 IU given orally once

Vitamin D3dietary

Vitamin D3 50,000 IU given orally once