Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Urinary calcium excretion
Study Overview
Brief Summary
The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.
Detailed Description
The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.
Patients will do weekly blood sampling and 24 hour urine collection every second week.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic post surgical hypoparathyroidism diagnosed > 1 year ago
- •Age ≥ 18 years
- •Require treatment with active vitamin D ≥ 1 µg/day
- •Ionized plasma calcium between 1.15-1.25 mmol/L
- •25(OH)D vitamin ≥ 50 nmol/L
- •Plasma magnesium > 0.65 mmol/L
- •Able to read and understand Danish
- •Willing and able to sign the informed consent form
Exclusion Criteria
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
- •Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago
- •Pregnancy, pregnancy plans, or breastfeeding < 1 year ago
- •Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg
- •Plasma potassium < 3.5 mmol/L
- •Any current disease that might affect the calcium metabolism such as but not limited to:
- •Recent prolonged immobility
- •Untreated diabetes (HbA1c > 53 mmol/mol)
- •Severe liver disease or hepatic encephalopathy
- •Untreated thyroid disease
- •Current disease that might affect gastrointestinal absorption
- •Use of medications such as lithium or diuretics within 4 weeks prior to start of treatment
- •Known allergy or sensitivity to Indapamide, its excipients or sulfonamides
- •Known galactosemia, lactase deficiency, or glucose-galactose malabsorption
Arms & Interventions
Indapamide
14 days with active drug Indapamide 1.5 mg/day
Intervention: Indapamide 1.5 MG SR (Drug)
Placebo
14 days with placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Urinary calcium excretion
Time Frame: Day 15
investigate the effect of daily treatment with Indapamide for 14 days compared to placebo on urinary calcium excretion in patients with chronic post-surgical hypoparathyroidism
Secondary Outcomes
- Ionized calcium(Day 15)
- Sodium diet(Day 15)
- Safety (blood pressure)(Day 15)
Investigators
Lars Rejnmark
MD, Ph.D., DMSc, prof
University of Aarhus