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Vitamin D and Genetics in Nutritional Rickets

NCT00949832 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2012-07-04

No results posted yet for this study

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.

Conditions

  • Nutritional Rickets

Interventions

DIETARY_SUPPLEMENT

Vitamin D + Calcium

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

DIETARY_SUPPLEMENT

Calcium

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

DIETARY_SUPPLEMENT

Vitamin D2

50,000 IU given orally once

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 50,000 IU given orally once

Sponsors & Collaborators

  • Jos University Teaching Hospital

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Thomas D Thacher, MD · Mayo Clinic, Jos University Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Nigeria

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949832 on ClinicalTrials.gov