In short
Clinical trials are studying MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE to see whether it can help after thyroid surgery. The main trial looks at whether it lowers the risk of chronic postoperative hypoparathyroidism and measures results in people with this complication after surgery.
Key points
- One clinical trial is studying MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE in people with postoperative hypoparathyroidism after thyroid surgery. It is a Phase 3, randomized, double-blind, placebo-controlled study. The trial plans to enroll 500 people at a single center. The main question is whether 8-day oral treatment can lower the chance of chronic hypoparathyroidism 6 months after surgery. The main outcome looks at low corrected calcium and PTH levels that remain low over time.
Trial overview
The available trial studies MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE in people with postoperative hypoparathyroidism after thyroid surgery. The study is called “MAGNEFFICIENT” and it is described as a prospective, randomized, double-blind, placebo-controlled, single-center clinical trial.
The trial is authorised and is listed as a Phase 3 interventional study. The brief summary says the study is testing whether 8-day oral magnesium aspartate can reduce chronic postoperative hypoparathyroidism at 6 months.
Study design and treatment groups
This is a randomized study, which means people are assigned to treatment groups by chance. It is also double-blind, which means the participants and the study team do not know who receives the active treatment or the placebo during the study.
The trial compares two oral treatments: TROFOCARD® max and a placebo that has the same composition as the investigational product except for the active substance. A placebo is a look-alike treatment used to help show whether the study drug makes a real difference.
Who can participate
The study is focused on people with postoperative hypoparathyroidism after thyroid surgery. The source data does not give more detailed entry rules, such as age limits or other medical conditions.
This means the main target population is patients who developed this problem after having their thyroid removed or treated by surgery.
What the trial is measuring
The main endpoint is the incidence of chronic postoperative hypoparathyroidism 6 months after surgery. An endpoint is the main result a clinical trial measures to see if the treatment works.
The trial defines this outcome as persistently low corrected calcium and PTH values when vitamin D or calcium has not been stopped. Corrected calcium is a blood calcium value adjusted to give a more accurate result, and PTH means parathyroid hormone, which helps control calcium levels.
Trial status and size
The trial status is Authorised. The planned enrollment is 500 people, which means the study aims to include 500 participants in total.
The study is single-center, so it is being carried out at one study site. This type of design can help keep the study process consistent across all participants.