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Studies With Vitamin D

This study is ongoing, but not recruiting participants.

Study NCT00001151. Last updated on October 28, 2008. Information provided by National Institutes of Health Clinical Center (CC)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Studies With Vitamin D
Official Title ^†	Studies With 1,25-Dihydroxycholecalciferol
Brief Summary	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.
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: 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. 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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment
Primary Outcome Measure ^†	Normal serum calcium concentration. [ Time Frame: Throughout drug administration. ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†
Condition ^†	Hypocalcemia Rickets
Intervention ^†	Drug: 1,25-Dihydroxycholecalciferol
MEDLINE PMIDs	4267263, 4357855, 4134407
Links	NIH Clinical Center Detailed Web Page

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	200
Start Date ^†	March 1976
Completion Date
Eligibility Criteria ^†	INCLUSION CRITERIA: Patients with hereditary resistance to calcitrol.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00001151
Organization ID	760081
Secondary IDs ^††	76-DK-0081
Study Sponsor ^†	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^††
Investigators ^†
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	February 2008
First Received Date ^†	November 3, 1999
Last Updated Date	October 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.