Drug interaction study between thyroid hormones and magnesium preparations in healthy subjects

Switzerland (ICTRP)

ID di studio ICTRP
ISRCTN18075783 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Single Centre Drug-Drug Interaction study with Levothyroxine/Magnesium-Citrate and Levothyroxine/Magnesium-Aspartate in healthy subjects (BASEC)

Titolo accademico
Single Centre Drug-Drug Interaction study with Levothyroxine/Magnesium-Citrate and Levothyroxine/Magnesium-Aspartate in healthy subjects (ICTRP)

Titolo pubblico
Drug interaction study with thyroid hormone and magnesium preparation in healthy volunteers (ICTRP)

Malattie studiate
Hypothyroidism
Nutritional, Metabolic, Endocrine (ICTRP)

Intervento studiato
Cross-over study with three groups. Each of the three treatments is during only 360 minutes: The time required to take the blood samples. A wash-out phase of min. 4 weeks is planned between each treatment. No specific follow-up is planned.
Group 1: One dose of Magnesium-Aspartate (10 mmol) in powder form, taken orally along with levothyroxine 1 mg
Group 2: One dose of Magnesium-Citrate (300 mg) in powder form, taken orally along with levothyroxine 1 mg, compared to
Group 3: One dose of levothyroxine 1 mg alone

Randomization: Due to the cross-over design of the trial, subjects will receive all treatments. The subjects will be block-randomized to three different treatment sequences in a 1:1:1 fashion with a block size of 6. Treatment sequences are chosen to ensure that each treatment appears once in each position (1st, 2nd, 3rd), ABC, BCA and CAB, A being levothyroxine alone, B being levothyroxine + magnesium citrate and C being levothyroxine + magnesium aspartate. The randomization list is prepared in advance by the trial statistician, and allocation concealment will be handled via sequentially numbered, opaque and sealed envelopes by a person at the study center that is not involved in the trial. Only after sealing, the envelopes are handed to the investigators. After inclusion of a participant, the four-digit-number assigned to the participant is written in wet ink on the envelope, before the seal is broken. The envelopes are opened according to their sequential number. Should a participant decide to terminate the study early, the sequences are re-used after all envelopes have been used up (for the 13th participant who replaces the participant that did not complete all visits). (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Open-label drug-drug-interaction study with cross-over design (Safety) (ICTRP)

Criteri di inclusione/esclusione
Gender: Both
Inclusion criteria: 1. Age 18-65 years
2. Informed Consent as documented by signature (ICTRP)

Exclusion criteria: 1. Contraindications to the drugs under study, e.g. known hypersensitivity or allergy
2. Need for any kind of drug therapy for the duration of the study
3. Women who are pregnant or breastfeeding
4. Intention to become pregnant during the course of the study
5. Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration. Female participants who are surgically sterilised / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
6. Other clinically significant concomitant disease states (e.g., renal failure, thyroid dysfunction, cardiovascular disease, arterial hypertension, any other medical condition that could lead to an albumin deficiency such as anorexia etc.)
7. Abnormal findings in the screening tests (laboratory, ECG, physical examination).
8. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
9. Participation in another study with investigational drug within the 30 days preceding and during the present study
10. Previous enrolment into the current study
11. Enrolment of the investigator, his/her family members, employees and other dependent persons

Endpoint primari e secondari
AUC of total thyroxin in the serum up to 6 hours after ingestion of levothyroxine, with measurements at 0 min, 30 min, 60 min, 120 min, 240 min and 360 min. (ICTRP)

1. Cmax of total thyroxin in the serum during a 6-hour period after ingestion of levothyroxine
2. Tmax of total thyroxin in the serum during a 6-hour period after ingestion of levothyroxine (ICTRP)

Data di registrazione
17.10.2023 (ICTRP)

Inclusione del primo partecipante
01.12.2023 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
J?r?me Bonzon, jerome.bonzon@usz.ch, +41 (0)442554074 (ICTRP)

ID secondari
Nil known, Nil known, 2.1 (ICTRP)

Risultati-Dati individuali dei partecipanti
Published as a supplement to the results publicationPlanned publication in a high-impact peer-reviewed journal. (ICTRP)

Ulteriori informazioni sullo studio
https://www.isrctn.com/ISRCTN18075783 (ICTRP)