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Vitamin D and Genetics in Nutritional Rickets

This study has been completed.
Sponsor:
Collaborator:
Jos University Teaching Hospital
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00949832
First received: July 29, 2009
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Nutritional Rickets
 Dietary Supplement: Vitamin D + Calcium
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D2
Dietary Supplement: Vitamin D3
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Vitamin D and Genetics in Nutritional Rickets

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • XR healing of rickets [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alkaline phosphatase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Serum calcium [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 25-hydroxyvitamin D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 1,25-dihydroxyvitamin D [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Calcium absorption [ Time Frame: 1 week ]

Enrollment: 109
Study Start Date: January 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Calcium supplementation
 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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with calcium or vitamin D in preceding 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949832

Locations
Nigeria
Jos University Teaching Hospital
Jos, Plateau, Nigeria, 930001
Sponsors and Collaborators
Mayo Clinic
Jos University Teaching Hospital
Investigators
Principal Investigator: Thomas D Thacher, MD Mayo Clinic, Jos University Teaching Hospital
  More Information

Publications:

Responsible Party: Thomas D. Thacher, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00949832     History of Changes
Other Study ID Numbers: 07-006041
Study First Received: July 29, 2009
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
rickets
calcium
vitamin D
nutrition
child

Additional relevant MeSH terms:
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium, Dietary
 Cholecalciferol
Ergocalciferols
Vitamin D
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013