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MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE

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.

Table of contents

Trial overview

The available trial studies MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE in people with postoperative hypoparathyroidism after thyroid surgery.[1] The study is called “MAGNEFFICIENT” and it is described as a prospective, randomized, double-blind, placebo-controlled, single-center clinical trial.[1]

The trial is authorised and is listed as a Phase 3 interventional study.[1] The brief summary says the study is testing whether 8-day oral magnesium aspartate can reduce chronic postoperative hypoparathyroidism at 6 months.[1]

Study design and treatment groups

This is a randomized study, which means people are assigned to treatment groups by chance.[1] 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.[1]

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.[1] A placebo is a look-alike treatment used to help show whether the study drug makes a real difference.[1]

Who can participate

The study is focused on people with postoperative hypoparathyroidism after thyroid surgery.[1] The source data does not give more detailed entry rules, such as age limits or other medical conditions.[1]

This means the main target population is patients who developed this problem after having their thyroid removed or treated by surgery.[1]

What the trial is measuring

The main endpoint is the incidence of chronic postoperative hypoparathyroidism 6 months after surgery.[1] An endpoint is the main result a clinical trial measures to see if the treatment works.[1]

The trial defines this outcome as persistently low corrected calcium and PTH values when vitamin D or calcium has not been stopped.[1] Corrected calcium is a blood calcium value adjusted to give a more accurate result, and PTH means parathyroid hormone, which helps control calcium levels.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 500 people, which means the study aims to include 500 participants in total.[1]

The study is single-center, so it is being carried out at one study site.[1] This type of design can help keep the study process consistent across all participants.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2025-522839-33-00Phase 3Postoperative Hypoparathyroidism after thyroid surgeryAuthorised500

FAQ

  • What is being studied in trials of MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE? The main study is testing whether oral MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE can reduce chronic postoperative hypoparathyroidism after thyroid surgery. It compares the active treatment with a placebo, which is a look-alike treatment without the active substance.
  • Who can take part in these trials? The trial focuses on people with postoperative hypoparathyroidism after thyroid surgery. The source data does not list more detailed participation rules.
  • What phase is the trial? The trial is a Phase 3 study. Phase 3 trials are larger studies that check how well a treatment works and continue to collect safety information.
  • What outcome is the trial measuring? The main outcome is the number of people who have chronic postoperative hypoparathyroidism 6 months after surgery. The study defines this by low corrected calcium and PTH levels that stay low without stopping vitamin D or calcium.
  • How many people are planned for the study? The trial plans to enroll 500 people. This makes it a fairly large study for one center.

Ongoing Clinical Trials on MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE

  • A study testing magnesium aspartate to prevent long-term low parathyroid hormone levels in patients after thyroid surgery

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

Glossary

  • Postoperative hypoparathyroidism: A condition that can happen after surgery, especially thyroid surgery, when the parathyroid glands do not make enough hormone.
  • Thyroid surgery: An operation on the thyroid gland, which is in the neck.
  • Placebo: A treatment that looks like the study drug but does not contain the active substance.
  • Double-blind: A study design where neither the participants nor the study team knows who gets the active treatment or the placebo.
  • Randomized: People are assigned to treatment groups by chance, not by choice.
  • Phase 3: A later stage of clinical research that usually includes more people and checks how well a treatment works.
  • Interventional study: A study where researchers give a treatment and then measure the effects.
  • Primary outcome: The main result the researchers want to measure in the trial.
  • Corrected calcium: A calcium blood result adjusted to give a more accurate value.
  • PTH: Parathyroid hormone, a hormone that helps control calcium levels in the body.

References