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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001151 |
Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients suffering from disorders with Vitamin D resistance are unable to absorb calcium from food. Patients diagnosed with these disorders will be evaluated and treated with high doses of another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed throughout the study to avoid experiencing side effects from the medication.
Condition | Intervention | Phase |
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Hypocalcemia Rickets |
Drug: 1,25-Dihydroxycholecalciferol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Studies With 1,25-Dihydroxycholecalciferol |
Estimated Enrollment: | 200 |
Study Start Date: | March 1976 |
Patients with extreme resistance to 1,25-dihydroxyvitamin D will be evaluated and treated with high doses of 1,25-dihydroxyvitamin D3.
Plan: In previously untreated patients the study will be divided into a control and one or more treatment periods. During the control period, parathyroid status will be assessed by parameters nos. 1& 2 (below). In previously treated patients maintenance vitamin D will be gradually replaced with 1,25(OH)2D3. This will be accomplished by withdrawal of vitamin D and institution of 1,25(OH)2D3 when the serum calcium shows a downward trend.
1,25(OH)2D3 as 0.25 or 0.5 ug capsules (though IND 20,889) or as a solution of I microgram per ml will be administered orally. In most cases, because of consideration of time and expense, the cooperation of the patient's local physician will be enlisted. The following will be monitored:
The dose of 1,25(OH)2D3 will be 0.125 to 50.0 ug/day. Serum calcium will not be allowed to rise above the normal range (2.0 -2.4 mM at NIH). Should hypercalcemia occur, appropriate treatment will be initiated and the drug dosage will be decreased.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients with hereditary resistance to calcitrol.
Responsible Party: | National Institutes of Health ( Stephen J. Marx, M.D./National Institute of Diabetes and Digestive and Kidney Diseases ) |
Study ID Numbers: | 760081, 76-DK-0081 |
Study First Received: | November 3, 1999 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00001151 |
Health Authority: | United States: Federal Government |
Calciferol Hypocalcemia Rickets |
Vitamin D Deficiency Cholecalciferol Hypocalcemia Metabolic Diseases Avitaminosis Ergocalciferols Bone Diseases, Metabolic Dihydroxycholecalciferols Bone Diseases Calcitriol |
Calcium, Dietary Vitamin D Malnutrition Musculoskeletal Diseases Rickets Nutrition Disorders Water-Electrolyte Imbalance Metabolic disorder Deficiency Diseases |
Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |
Calcium Metabolism Disorders Membrane Transport Modulators Vitamins Therapeutic Uses Vasoconstrictor Agents Micronutrients |