| CTRI Number |
CTRI/2024/08/073037 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Prospective Randomised Control Trial To Study Efficacy
And Safety Of Thiazide Diuretic In Subjects With Idiopathic
Hypoparathyroidism |
|
Scientific Title of Study
|
A Prospective Randomised Control Trial To Study Efficacy
And Safety Of Thiazide Diuretic In Subjects With Idiopathic
Hypoparathyroidism |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soham Mukherjee |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Endocrinology PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914743222 |
| Fax |
|
| Email |
drsoham.mukherjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soham Mukherjee |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Endocrinology PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914743222 |
| Fax |
|
| Email |
drsoham.mukherjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soham Mukherjee |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Endocrinology PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914743222 |
| Fax |
|
| Email |
drsoham.mukherjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 160012 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr vivek jha |
Postgraduate Institute of Medical Education and Research(PGIMER) |
Chandigarh, India, 160012,Department of Endocrinology, Nehru Hospital Extension
Chandigarh
CHANDIGARH |
7340921011
vivekbpkihs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate institute of medical education and research,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E200||Idiopathic hypoparathyroidism, (2) ICD-10 Condition: E200||Idiopathic hypoparathyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug Hydrochlorothiazide |
Initially Patient will be given Hydrochlorothiazide 12.5mg/day and will be evaluated on day 5 and day 8 for serum calcium phosphorous potassium albumin and urine 24hrs etc
total Duration: 1 month |
| Comparator Agent |
Placebo |
Initially Patient will be given Placebo will be evaluated on day 5 and day 8 for serum calcium phosphorous potassium albumin and urine 24hrs
Total duration 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients fulfilling Criteria for diagnosis of hypoparathyroidism
Hypocalcemia
Hyperphosphatemia
Normal serum creatinine level
Low or inappropriately normal plasma iPTH at the time of diagnosis. |
|
| ExclusionCriteria |
| Details |
Chronic Kidney Disease (CKD)
Pregnancy and Lactation
Adrenal Insufficiency
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in Serum Calcium after Treatment with hydrochlorothiazide
in subjects with idiopathic Hypoparathyroidism. |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in 24hr urinary calcium, sodium & phosphorous excretion in subjects
with idiopathic hypoparathyroidism with hydrochlorothiazide (HCTZ)
treatment.
Change in Fractional Urinary Calcium Excretion in subjects with idiopathic
hypoparathyroidism with hydrochlorothiazide (HCTZ) treatment.
Change in bone turnover markers (CTX/P1NP) in subjects with idiopathic
hypoparathyroidism with hydrochlorothiazide (HCTZ) treatment.
Increase in plasma iPTH in subjects with idiopathic hypoparathyroidism with
hydrochlorothiazide (HCTZ) treatment. |
one month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Protocol for Maintaining Serum Calcium Levels (8-8.5 mg/dl)
Pre-Study Preparation
1. Inclusion Criteria Fulfillment
- Assess patients to ensure they meet the inclusion criteria for the study.
2. Active Vitamin D Dosage Adjustment
- Titrate the dose of Active Vitamin D by 0.25 µg/day to maintain serum calcium levels between 8.0 and 8.5 mg/dl.
- Maximum dose: 3 µg/day.
3. Monitoring
- Follow up with patients weekly to measure serum calcium (S. Ca) and phosphorus levels until the target calcium range is achieved.
- Once patients achieve target serum calcium levels, they can be directly recruited for the study.
4. Dietary Assessment
- Evaluate patients’ daily intake of calcium and phosphorus using a semi-quantitative food frequency questionnaire administered by a trained dietitian.
Study Enrollment and Initial Phase
5. Enrollment
- Enroll all subjects who fulfill the inclusion criteria.
6. Medication Continuation
- Instruct subjects to continue their usual medications along with calcium supplementation.
7. Dose Adjustment Period (Two Weeks)
- Adjust the dose of Active Vitamin D as needed to maintain serum calcium levels between 8.0 and 8.5 mg/dl.
Control Period
8. Diet Control Period (4-5 days)
- Provide all participants with a diet of constant calcium (600-1300 mg) and sodium (100-200 meq).
9. Baseline Measurements
- Record baseline vitals and conduct investigations as outlined in Annexure 1 for each study subject.
Randomization and Experimental Phase
10. Randomization
- Randomize participants into two groups (A and B) in a 1:1 ratio.
11. Experimental Intervention - Part 1
- Group A: Administer hydrochlorothiazide (HCTZ) 12.5 mg with a low-salt diet (50-100 meq/day).
- Group B: Administer placebo.
12. Day 4 Post-Intervention
- Measure the following parameters in both groups:
- Vitals: Blood Pressure (BP), Heart Rate (HR)
- Body weight, estimated Glomerular Filtration Rate (eGFR)
- Serum: Calcium, phosphorus, sodium, potassium, albumin, intact parathyroid hormone (iPTH), Vitamin D
- 24-hour urinary excretion: calcium, sodium, phosphorus, and fractional urinary calcium excretion.
13. Dose Adjustment
- If no contraindications, increase HCTZ dose to 25 mg from 12.5 mg on Day 4.
14. Day 7 Measurements
- Repeat all parameters measured on Day 4.
Washout Period
15. Intervention-Free Period
- Allow a washout period of 2 weeks where participants are free of any intervention.
Experimental Phase - Part 2 (Crossover)
16. Crossover Intervention
- Group A: Switch to placebo.
- Group B Switch to HCTZ (12.5 mg) with a low-salt diet.
17. Day 4 Post-Intervention
- Measure the same parameters as in the first part.
18. Dose Adjustment
- Increase HCTZ dose to 25 mg from 12.5 mg on Day 4 if no contraindications.
19. Day 7 Measurements
- Repeat all parameters measured on Day 4.
Extension Phase
20.Continuation with Experimental Drug
- Administer the experimental drug (HCTZ) to all participants at a dose of 12.5 mg or 25 mg as tolerated.
21. Follow-Up
- Monitor participants for 1 month for primary and secondary outcomes.
22. Outcome Assessment
- Conduct a final assessment of outcomes at the end of the study.
This protocol outlines a comprehensive approach to maintaining serum calcium levels within the target range and monitoring the effects of hydrochlorothiazide with a low-salt diet.
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