Vitamin D and Genetics in Nutritional Rickets
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|ClinicalTrials.gov Identifier: NCT00949832|
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : July 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Nutritional Rickets||Dietary Supplement: Vitamin D + Calcium Dietary Supplement: Calcium Dietary Supplement: Vitamin D2 Dietary Supplement: Vitamin D3||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Vitamin D and Genetics in Nutritional Rickets|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
U.S. FDA Resources
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 Name: ergocalciferol
Placebo Comparator: Calcium
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 Name: limestone
Active Comparator: Vitamin D2
Vitamin D2 response
Dietary Supplement: Vitamin D2
50,000 IU given orally once
Other Name: ergocalciferol
Active Comparator: Vitamin D3
Vitamin D3 response
Dietary Supplement: Vitamin D3
Vitamin D3 50,000 IU given orally once
Other Name: cholecalciferol
- XR healing of rickets [ Time Frame: 6 months ]
- Alkaline phosphatase [ Time Frame: 6 months ]
- Serum calcium [ Time Frame: 6 months ]
- 25-hydroxyvitamin D [ Time Frame: 6 months ]
- 1,25-dihydroxyvitamin D [ Time Frame: 2 weeks ]
- Calcium absorption [ Time Frame: 1 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949832
|Jos University Teaching Hospital|
|Jos, Plateau, Nigeria, 930001|
|Principal Investigator:||Thomas D Thacher, MD||Mayo Clinic, Jos University Teaching Hospital|