Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001151
Status:
TERMINATED
Last Update Posted:
2013-11-25
First Post:
1999-11-03
Brief Title:
Studies With 125-Dihydroxycholecalciferol
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies With 125-Dihydroxycholecalciferol
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated because of lack of drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 125-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 125-dihydroxyvitamin D will be evaluated and treated with high doses of 125-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 125OH2D3 This will be accomplished by withdrawal of vitamin D and institution of 125OH2D3 when the serum calcium shows a downward trend
125OH2D3 as 025 or 05 ug capsules though IND 20889 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 patients local physician will be enlisted The following will be monitored
1 Serum calcium phosphorusalkaline phosphatasecreatinine 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 phosphoruscreatinine and cAMP before therapy and when appropriate during therapy
The dose of 125OH2D3 will be 0125 to 500 ugday Serum calcium will not be allowed to rise above the normal range 20 -24 mM at NIH Should hypercalcemia occur appropriate treatment will be initiated and the drug dosage will be decreased
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 125OH2D3 This will be accomplished by withdrawal of vitamin D and institution of 125OH2D3 when the serum calcium shows a downward trend
125OH2D3 as 025 or 05 ug capsules though IND 20889 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 patients local physician will be enlisted The following will be monitored
1 Serum calcium phosphorusalkaline phosphatasecreatinine 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 phosphoruscreatinine and cAMP before therapy and when appropriate during therapy
The dose of 125OH2D3 will be 0125 to 500 ugday Serum calcium will not be allowed to rise above the normal range 20 -24 mM at NIH Should hypercalcemia occur appropriate treatment will be initiated and the drug dosage will be decreased
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 76-DK-0081 | OTHER | 76-DK-0081 | None |