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Studies With 1,25-Dihydroxycholecalciferol

This study has been terminated.
(Terminated because of lack of drug supply)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001151
First Posted: November 4, 1999
Last Update Posted: November 25, 2013
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.
Information provided by (Responsible Party):
Stephen Marx, M.D., National Institutes of Health Clinical Center (CC)
  Purpose
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
Hypocalcemia Rickets Drug: 1,25-Dihydroxycholecalciferol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studies With 1,25-Dihydroxycholecalciferol

Resource links provided by NLM:


Further study details as provided by Stephen Marx, M.D., National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Number of Participants With Normal Serum Calcium Concentrations [ Time Frame: 1 year average ]
    Normal calcium concentration 8.2-10.6 mg/dL


Enrollment: 6
Study Start Date: March 1976
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug treatment
1,25-Dihydroxycholecalciferol 5 ug orally per day for 2 years
Drug: 1,25-Dihydroxycholecalciferol
Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day.

Detailed Description:

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:

  1. Serum calcium, phosphorus,alkaline phosphatase,creatinine at twice weekly intervals. After a maintenance dose has been established, this will be decreased to a monthly, and subsequently 3-6 monthly interval.
  2. Urine calcium, phosphorus,creatinine and cAMP before therapy and, when appropriate, during therapy.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients with hereditary resistance to calcitrol.

  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): NCT00001151


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Stephen J Marx, MD NIDDK/NIH
  More Information

Publications:
Responsible Party: Stephen Marx, M.D., Chief of the Metabolic Diseases Branch of NIDDK/NIH, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001151     History of Changes
Other Study ID Numbers: 760081
76-DK-0081 ( Other Identifier: 76-DK-0081 )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: November 12, 2010
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: June 2013

Keywords provided by Stephen Marx, M.D., National Institutes of Health Clinical Center (CC):
Calciferol
Hypocalcemia
Rickets

Additional relevant MeSH terms:
Hypocalcemia
Rickets
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcitriol
Dihydroxycholecalciferols
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents