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| Name | Class |
|---|---|
| Jos University Teaching Hospital | OTHER |
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The purpose of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D + Calcium | Active Comparator | Vitamin D and calcium supplementation |
|
| Calcium | Placebo Comparator | Calcium supplementation |
|
| Vitamin D2 | Active Comparator | Vitamin D2 response |
|
| Vitamin D3 | Active Comparator | Vitamin D3 response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D + Calcium | Dietary Supplement | Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| XR healing of rickets | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alkaline phosphatase | 6 months | |
| Serum calcium | 6 months | |
| 25-hydroxyvitamin D |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas D Thacher, MD | Mayo Clinic, Jos University Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jos University Teaching Hospital | Jos | Plateau State | 930001 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10451461 | Background | 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. | |
| 15531695 | Background | 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. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D012279 | Rickets |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002118 | Calcium |
| D004872 | Ergocalciferols |
| D002119 | Calcium Carbonate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Calcium | Dietary Supplement | 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 | Dietary Supplement | 50,000 IU given orally once |
|
|
| Vitamin D3 | Dietary Supplement | Vitamin D3 50,000 IU given orally once |
|
|
| 6 months |
| 1,25-dihydroxyvitamin D | 2 weeks |
| Calcium absorption | 1 week |
| 17137904 | Background | 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. |
| 11092401 | Background | 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. |
| 33305842 | Derived | 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. |
| 24748637 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017610 | Calcium Compounds |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |