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

Switzerland (ICTRP)

ICTRP Studien-ID
ISRCTN73459064 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Single Centre Drug-Drug Interaction study with Levothyroxine and Zinc-D-gluconate in healthy subjects (BASEC)

Wissenschaftlicher Titel
Single centre drug-drug interaction study with levothyroxine and zinc-D-gluconate in healthy subjects (ICTRP)

Öffentlicher Titel
Drug interaction study with thyroid hormone and zinc preparation in healthy volunteers (ICTRP)

Untersuchte Krankheit(en)
Hypothyroidism
Nutritional, Metabolic, Endocrine (ICTRP)

Untersuchte Intervention
This is a cross-over study with three groups. Each of the three treatments will last for 360 minutes, which is the duration needed for blood sample collection. A washout period of at least 4 weeks will be scheduled between each treatment. No additional follow-up is planned for the study.

Group 1: One dose of zinc-D-gluconate (70 mg, corresponding to 10 mg zinc) in tablet form, taken orally along with levothyroxine 1 mg
Group 2: One dose of zinc-D-gluconate (350 mg, corresponding to 50 mg zinc) in tablet 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 + zinc 10 mg and C being levothyroxine + zinc 50 mg. 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 who is not involved in the trial. Only after sealing will the envelopes be handed to the investigators. After the 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 16th participant who replaces the participant who did not complete all visits). (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Open-label drug-drug-interaction study with cross-over design (Safety) (ICTRP)

Ein-/Ausschlusskriterien
Gender: Both
Inclusion criteria: 1. Age 18-65 years old
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 oral drug therapy (including oral contraceptive or nutritional supplements) for the duration of the study, except for the symptomatic treatment of common conditions like headache, musculoskeletal pain, common cold, gastritis, nausea and diarrhoea with medication containing paracetamol, non-steroidal anti-inflammatory drugs, meclizine, domperidone, and loperamide, as long they are taken on an as-per-need basis and not 72 hours before a visit.
3. Planned intake of oral calcium, magnesium, zinc or iron supplements for the duration of the study
4. 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.)
5. Abnormal findings in the screening tests (laboratory, ECG, physical examination).
6. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
7. Participation in another study with an investigational drug within the 30 days preceding and during the present study
8. Previous enrolment into the current study
9. Enrolment of the investigator, his/her family members, employees and other dependent persons

Applicable only to female participants:
1. Women who are pregnant or breastfeeding
2. Intention to become pregnant during the study
3. 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 (defined as sexual abstinence with men (except in case of medically proven male sterility of the male sexual partner), use of a condom, use of an intrauterine device (contraceptive coil with or without hormones), use of a dermal or subcutaneous device or a subcutaneous injection with hormones (such as Evra? or Implanon?), use of a vaginal hormonal device (such as NuvaRing?)) 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 childbearing potential.

Primäre und sekundäre Endpunkte
AUC of total thyroxin in the serum up to 6 hours after ingestion of levothyroxine measured using electrochemiluminescence immunoassay (ECLIA) at 0, 30, 60, 120, 240 and 360 min (ICTRP)

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

Registrierungsdatum
14.08.2024 (ICTRP)

Einschluss des ersten Teilnehmers
26.07.2024 (ICTRP)

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
J?r?me Bonzon, jerome.bonzon@usz.ch, +41 44 255 40 74 (ICTRP)

Sekundäre IDs
Nil known, Nil known, 1.2 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
YesPublished as a supplement to the results publication. The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. (ICTRP)

Weitere Informationen zur Studie
https://www.isrctn.com/ISRCTN73459064 (ICTRP)