Vitamin D and Genetics in Nutritional Rickets
Condition: Nutritional Rickets
MeSH terms: Rickets
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Vitamin D + Calcium; Calcium; Vitamin D2; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months; 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; 50,000 IU given orally once; Vitamin D3 50,000 IU given orally once
Other intervention name(s): ergocalciferol; limestone; ergocalciferol; cholecalciferol
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rickets; calcium; vitamin D; nutrition; child