Vitamin D and Genetics in Nutritional Rickets

July 3, 2012 updated by: Mayo Clinic

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous studies of Nigerian children with rickets demonstrated the superiority of calcium over vitamin D in producing healing. It is not known whether the addition of vitamin D to calcium will produce a better response to treatment than calcium alone in Nigerian children. A previous study suggested the possibility that vitamin D may augment the effect of calcium. We will compare the response of rickets to calcium with and without vitamin D. In addition, very little human data clearly demonstrates the effect of supplemental vitamin D on calcium absorption. We will assess whether oral vitamin D increases the already high calcium absorption even further.

Recent published data indicate that the increase in serum 25-hydroxyvitamin D may be more sustained with vitamin D3 than with vitamin D2. We will compare the response of Nigerian children with and without rickets to orally administered vitamin D3 and vitamin D2.

Because nutritional rickets tends to run in families, we will also examine amplified DNA for evidence of mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh. Families possessing a recently identified 25-hydroxylase mutation will be given oral vitamin D2 and vitamin D3 to determine the functional status of the 25-hydroxylase enzyme.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Plateau
      • Jos, Plateau, Nigeria, 930001
        • Jos University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical features of rickets
  • Active rickets on X-ray

Exclusion Criteria:

  • Treatment with calcium or vitamin D in preceding 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D + Calcium
Vitamin D and calcium supplementation
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
Other Names:
  • ergocalciferol
Placebo Comparator: Calcium
Calcium supplementation
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
Other Names:
  • limestone
Active Comparator: Vitamin D2
Vitamin D2 response
Dietary supplement: Vitamin D2
50,000 IU given orally once
Other Names:
  • ergocalciferol
Active Comparator: Vitamin D3
Vitamin D3 response
Dietary supplement: Vitamin D3
Vitamin D3 50,000 IU given orally once
Other Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
XR healing of rickets
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
1,25-dihydroxyvitamin D
Time Frame: 2 weeks
2 weeks
Alkaline phosphatase
Time Frame: 6 months
6 months
Serum calcium
Time Frame: 6 months
6 months
25-hydroxyvitamin D
Time Frame: 6 months
6 months
Calcium absorption
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Jos University Teaching Hospital

Investigators

  • Principal Investigator: Thomas D Thacher, MD, Mayo Clinic, Jos University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

July 4, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-006041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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