Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
500
Countries
1
Sites
1
Postoperative Hypoparathyroidism after thyroid surgery.
To determine whether 8-day oral magnesium aspartate (243 mg/day) reduces chronic postoperative hypoparathyroidism at 6 months.
Key facts
- Sponsor
- Henry Dunant Hospital Center
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Decision date (initial)
- 2025-10-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Efficacy
To determine whether 8-day oral magnesium aspartate (243 mg/day) reduces chronic postoperative hypoparathyroidism at 6 months.
Secondary objectives 2
- To evaluate the effect of magnesium on temporary and prolonged hypoparathyroidism.
- To assess changes in calcium-D replacement needs postoperatively.
Conditions and MedDRA coding
Postoperative Hypoparathyroidism after thyroid surgery.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adults aged 18–90 years scheduled for total thyroidectomy.
- With or without lymph node dissection, for any benign or malignant indication.
- Able to provide written informed consent.
- No history of parathyroid disorder or calcium/magnesium metabolism disorder.
Exclusion criteria 8
- Pre-existing hypoparathyroidism or hyperparathyroidism.
- Renal insufficiency (eGFR <60 mL/min).
- Active malabsorption syndromes.
- Current or chronic use of magnesium supplementation.
- Medications affecting calcium/magnesium (e.g., diuretics).
- Known intolerance to magnesium therapy.
- Unwillingness to comply with study visits or procedures.
- Patients with comorbidities potentially exacerbated by magnesium supplementation, including: • Cardiac arrhythmias (e.g., AV block, bradyarrhythmias) • Myasthenia gravis • Severe gastrointestinal disorders affecting absorption (e.g., active IBD) • History of hypermagnesemia or magnesium toxicity • Concurrent use of medications with known magnesium interactions (e.g., aminoglycosides, digoxin, bisphosphonates, proton pump inhibitors).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of chronic postoperative hypoparathyroidism at 6 months post-surgery, defined by persistently low corrected calcium and PTH values in the absence of vitamin D or calcium discontinuation.
Secondary endpoints 4
- Incidence of temporary hypoparathyroidism at 30 days.
- Differences in replacement therapy needs (alfacalcidol, calcium carbonate, cholecalciferol) at Day 7, Month 1, 3, and 6.
- Safety/tolerability based on AE/SAE reports.
- Patient-reported symptoms of hypocalcemia.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8830162 · Product
- Active substance
- Magnesium L-Aspartate Hydrochloride Trihydrate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 486 mg milligram(s)
- Max total dose
- 2187 mg milligram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- A12CC05 — MAGNESIUM ASPARTATE
- Marketing authorisation
- 138465/28.11.2019
- MA holder
- UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Henry Dunant Hospital Center
- Sponsor organisation
- Henry Dunant Hospital Center
- Address
- 107 Mesogeion Avenue
- City
- Athens
- Postcode
- 115 26
- Country
- Greece
Scientific contact point
- Organisation
- Henry Dunant Hospital Center
- Contact name
- Kyriakos Vamvakidis
Public contact point
- Organisation
- Henry Dunant Hospital Center
- Contact name
- Kyriakos Vamvakidis
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Authorised, recruitment pending | 500 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | MAGNEFFICIENT | 3.3 |
| Protocol (for publication) | Full protocol MAGNEFFICIENT 2025 | 3.3 |
| Protocol (for publication) | Track changes to Magnefficient protocol | 1 |
| Recruitment arrangements (for publication) | Informed Consent and Patient Recruitment Procedure | 2 |
| Subject information and informed consent form (for publication) | 2 | |
| Subject information and informed consent form (for publication) | INFORMED CONSENT | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | smpc trofocard | 1.1 |
| Synopsis of the protocol (for publication) | 1 | |
| Synopsis of the protocol (for publication) | Protocol Summary Magnefficient | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-14 | Greece | Acceptable 2025-10-21
|
2025-10-22 |