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Vitamin D and Genetics in Nutritional Rickets

Vitamin D and Genetics in Nutritional Rickets

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00949832
Enrollment
109
Registered
2009-07-30
Start date
2004-01-31
Completion date
2007-04-30
Last updated
2012-07-04

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

Conditions

Nutritional Rickets

Keywords

rickets, calcium, vitamin D, nutrition, child

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.

Interventions

DIETARY_SUPPLEMENTVitamin 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_SUPPLEMENTCalcium

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_SUPPLEMENTVitamin D2

50,000 IU given orally once

DIETARY_SUPPLEMENTVitamin D3

Vitamin D3 50,000 IU given orally once

Sponsors

Jos University Teaching Hospital
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Treatment with calcium or vitamin D in preceding 30 days

Design outcomes

Primary

MeasureTime frame
XR healing of rickets6 months

Secondary

MeasureTime frame
Alkaline phosphatase6 months
Serum calcium6 months
25-hydroxyvitamin D6 months
1,25-dihydroxyvitamin D2 weeks
Calcium absorption1 week

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026