Official Title

Vitamin D and Genetics in Nutritional Rickets
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    vitamin d3 calcium ...
  • Study Participants

    109
The purpose of this study is:

To compare the response of rickets to calcium with and without vitamin D.
To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.
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 Started
Jan 31
2004
Primary Completion
Apr 30
2007
Study Completion
Apr 30
2007
Last Update
Jul 04
2012
Estimate

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

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

Dietary Supplement Vitamin D2

50,000 IU given orally once

  • Other names: ergocalciferol

Dietary Supplement Vitamin D3

Vitamin D3 50,000 IU given orally once

  • Other names: cholecalciferol

Vitamin D3 Active Comparator

Vitamin D3 response

Vitamin D + Calcium Active Comparator

Vitamin D and calcium supplementation

Calcium Placebo Comparator

Calcium supplementation

Vitamin D2 Active Comparator

Vitamin D2 response

Criteria

Inclusion Criteria:

Clinical features of rickets
Active rickets on X-ray

Exclusion Criteria:

Treatment with calcium or vitamin D in preceding 30 days
No Results Posted