Studies With 1,25-Dihydroxycholecalciferol

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00001151
Study type	Interventional
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Terminated
Phase	Phase 2
Start date	March 1976
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02892253` - Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia	N/A
Completed	`NCT05043584` - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions	N/A
Recruiting	`NCT05885256` - Clinical Assessment of Low Calcium In traUMa (CALCIUM)
Recruiting	`NCT04160637` - Is There Benefit From Early Postoperative PTH Monitoring?
Completed	`NCT00506103` - The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study	N/A
Recruiting	`NCT05585593` - Registry for Hypoparathyroidism Wuerzburg
Recruiting	`NCT04012476` - Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy	Phase 4
Recruiting	`NCT05586529` - Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia	N/A
Completed	`NCT01868750` - Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia	Phase 2
Terminated	`NCT00623974` - Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia	Phase 2
Completed	`NCT00668200` - Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®	Phase 4
Completed	`NCT00630214` - Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection	Phase 2
Not yet recruiting	`NCT03685877` - Hypocalcemia in Infants and Children
Completed	`NCT04750460` - Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).	Phase 3
Not yet recruiting	`NCT03063060` - The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy	N/A
Not yet recruiting	`NCT04304573` - Is Correcting Total Serum Calcium Levels Important After Thyroidectomy
Recruiting	`NCT05216419` - Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy	Phase 4
Recruiting	`NCT04775381` - Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation	Phase 3
Active, not recruiting	`NCT01632514` - Vitamin D Deficiency and Postoperative Hypocalcemia	Phase 4
Recruiting	`NCT05260255` - Effect of Vitamin D Supplement on Disease Activity in SLE	N/A