Vitamin analogues for hypoparathyroidism
Phase 2
- Conditions
- Health Condition 1: E200- Idiopathic hypoparathyroidism
- Registration Number
- CTRI/2019/05/019203
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All the patients with idiopathic hypoparathyroidism who are willing to participate and come for regular follow up for at least three months from the date of achieving ideal control serum calcium level between 8.0-9.5 mg/dl
Exclusion Criteria
Suboptimal calcium control with serum calcium less than 8.0 mg/dl,
History of poor compliance with follow up and or drugs in the previous trials
Not willing to visit at the designated interval of every 15 days during adjustment of therapy
history of any other active illness or hypocalcemic seizures during last six months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ability to achieve ideal control as indicated by serum calcium between 8.0-9.5, serum phosphate less than 4.5 mg/dl and urine calcium creatinine excretion ratio not more than 0.20 mg/mg in two study armsTimepoint: 12 weeks after the stable serum calcium is achieved on calcitriol and alphacalcidol groups <br/ ><br>
- Secondary Outcome Measures
Name Time Method Determination of equivalence dose of calcitriol and alfacalcidol for optimal calcium control in idiopathic hypoparathroidismTimepoint: three months;Differences in the serum FGF23 and 1,25 dihdroxy vitamin D levels at attainemnet of optical calcium control in the two study armsTimepoint: Three months