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Vitamin D and Genetics in Nutritional Rickets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949832
First Posted: July 30, 2009
Last Update Posted: July 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Jos University Teaching Hospital
Information provided by:
Mayo Clinic
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Vitamin D and Genetics in Nutritional Rickets

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • XR healing of rickets [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas D. Thacher, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00949832     History of Changes
Other Study ID Numbers: 07-006041
First Submitted: July 29, 2009
First Posted: July 30, 2009
Last Update Posted: July 4, 2012
Last Verified: July 2012

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

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