Vitamin D and Genetics in Nutritional Rickets

Nutritional Rickets Clinical Trial

Official title:

Vitamin D and Genetics in Nutritional Rickets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949832
• Other study ID #: 07-006041
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2009
• Last updated: July 3, 2012
• Start date: January 2004
• Est. completion date: April 2007

Study information

• Verified date: July 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 16 Years

Eligibility

Inclusion Criteria:

• Clinical features of rickets

• Active rickets on X-ray

Exclusion Criteria:

• Treatment with calcium or vitamin D in preceding 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nutritional Rickets
• Rickets

Intervention

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
• 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
• Vitamin D2
50,000 IU given orally once
• Vitamin D3
Vitamin D3 50,000 IU given orally once

Locations

Country	Name	City	State
Nigeria	Jos University Teaching Hospital	Jos	Plateau

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Jos University Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

References & Publications (4)

Fischer PR, Thacher TD, Pettifor JM, Jorde LB, Eccleshall TR, Feldman D. Vitamin D receptor polymorphisms and nutritional rickets in Nigerian children. J Bone Miner Res. 2000 Nov;15(11):2206-10. — View Citation

Graff M, Thacher TD, Fischer PR, Stadler D, Pam SD, Pettifor JM, Isichei CO, Abrams SA. Calcium absorption in Nigerian children with rickets. Am J Clin Nutr. 2004 Nov;80(5):1415-21. — View Citation

Thacher TD, Fischer PR, Isichei CO, Pettifor JM. Early response to vitamin D2 in children with calcium deficiency rickets. J Pediatr. 2006 Dec;149(6):840-4. — View Citation

Thacher TD, Fischer PR, Pettifor JM, Lawson JO, Isichei CO, Reading JC, Chan GM. A comparison of calcium, vitamin D, or both for nutritional rickets in Nigerian children. N Engl J Med. 1999 Aug 19;341(8):563-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	XR healing of rickets		6 months	No
Secondary	Alkaline phosphatase		6 months	No
Secondary	Serum calcium		6 months	Yes
Secondary	25-hydroxyvitamin D		6 months	No
Secondary	1,25-dihydroxyvitamin D		2 weeks	No
Secondary	Calcium absorption		1 week