Vitamin D and Genetics in Nutritional Rickets

Phase 4

Completed

• Conditions: Nutritional Rickets
• Interventions: Dietary Supplement: Vitamin D + Calcium; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D2; Dietary Supplement: Vitamin D3

• Registration Number: NCT00949832
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

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

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Exclusion Criteria

• Treatment with calcium or vitamin D in preceding 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D + Calcium	Vitamin D + Calcium	Vitamin D and calcium supplementation
Calcium	Calcium	Calcium supplementation
Vitamin D2	Vitamin D2	Vitamin D2 response
Vitamin D3	Vitamin D3	Vitamin D3 response

Primary Outcome Measures

Name	Time	Method
XR healing of rickets	6 months

Secondary Outcome Measures

Name	Time	Method
Alkaline phosphatase	6 months
Serum calcium	6 months
25-hydroxyvitamin D	6 months
1,25-dihydroxyvitamin D	2 weeks
Calcium absorption	1 week

Trial Locations

Locations (1)

Jos University Teaching Hospital; 🇳🇬 Jos, Plateau, Nigeria