Vitamin D and Genetics in Nutritional Rickets
Primary Purpose
Nutritional Rickets
Status
Completed
Phase
Phase 4
Locations
Nigeria
Study Type
Interventional
Intervention
Vitamin D + Calcium
Calcium
Vitamin D2
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Nutritional Rickets focused on measuring rickets, calcium, vitamin D, nutrition, child
Eligibility Criteria
Inclusion Criteria:
- Clinical features of rickets
- Active rickets on X-ray
Exclusion Criteria:
- Treatment with calcium or vitamin D in preceding 30 days
Sites / Locations
- Jos University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Vitamin D + Calcium
Calcium
Vitamin D2
Vitamin D3
Arm Description
Vitamin D and calcium supplementation
Calcium supplementation
Vitamin D2 response
Vitamin D3 response
Outcomes
Primary Outcome Measures
XR healing of rickets
Secondary Outcome Measures
Alkaline phosphatase
Serum calcium
25-hydroxyvitamin D
1,25-dihydroxyvitamin D
Calcium absorption
Full Information
NCT ID
NCT00949832
First Posted
July 29, 2009
Last Updated
July 3, 2012
Sponsor
Mayo Clinic
Collaborators
Jos University Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00949832
Brief Title
Vitamin D and Genetics in Nutritional Rickets
Official Title
Vitamin D and Genetics in Nutritional Rickets
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Jos University Teaching Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Rickets
Keywords
rickets, calcium, vitamin D, nutrition, child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D + Calcium
Arm Type
Active Comparator
Arm Description
Vitamin D and calcium supplementation
Arm Title
Calcium
Arm Type
Placebo Comparator
Arm Description
Calcium supplementation
Arm Title
Vitamin D2
Arm Type
Active Comparator
Arm Description
Vitamin D2 response
Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
Vitamin D3 response
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D + Calcium
Other Intervention Name(s)
ergocalciferol
Intervention Description
Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Other Intervention Name(s)
limestone
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
ergocalciferol
Intervention Description
50,000 IU given orally once
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Vitamin D3 50,000 IU given orally once
Primary Outcome Measure Information:
Title
XR healing of rickets
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alkaline phosphatase
Time Frame
6 months
Title
Serum calcium
Time Frame
6 months
Title
25-hydroxyvitamin D
Time Frame
6 months
Title
1,25-dihydroxyvitamin D
Time Frame
2 weeks
Title
Calcium absorption
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical features of rickets
Active rickets on X-ray
Exclusion Criteria:
Treatment with calcium or vitamin D in preceding 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D Thacher, MD
Organizational Affiliation
Mayo Clinic, Jos University Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jos University Teaching Hospital
City
Jos
State/Province
Plateau
ZIP/Postal Code
930001
Country
Nigeria
12. IPD Sharing Statement
Citations:
PubMed Identifier
10451461
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. doi: 10.1056/NEJM199908193410803.
Results Reference
background
PubMed Identifier
15531695
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. doi: 10.1093/ajcn/80.5.1415.
Results Reference
background
PubMed Identifier
17137904
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. doi: 10.1016/j.jpeds.2006.08.070.
Results Reference
background
PubMed Identifier
11092401
Citation
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. doi: 10.1359/jbmr.2000.15.11.2206.
Results Reference
background
PubMed Identifier
33305842
Citation
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Results Reference
derived
PubMed Identifier
24748637
Citation
Thacher TD, Fischer PR, Pettifor JM. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Arch Dis Child. 2014 Sep;99(9):807-11. doi: 10.1136/archdischild-2013-305275. Epub 2014 Apr 19.
Results Reference
derived
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Vitamin D and Genetics in Nutritional Rickets
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