Status:
COMPLETED
Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Lead Sponsor:
Lesaffre International
Conditions:
Zinc Deficiency
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts use...
Eligibility Criteria
Inclusion
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Sex: female (premenopausal), male
- Age: 20 - 50 years
- BMI ≥19 or ≤30 kg/m²
- Non-smoker
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology
Exclusion
- Relevant history or presence of any medical disorder, potentially interfering with this trial
- For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Migraine or regular headache, intense premenstrual symptoms
- Coffee consumption \>3 cups / day
- Blood donation within 2 months prior to trial start or during trial
- Regular intake of mineral supplements within 4 weeks prior to trial start or during trial
- Chronic intake of substances affecting the intestinal absorption of zinc
- Vegetarians / vegans
- Drug-, alcohol- and medication abuses
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance
- Known pregnancy, breast feeding or intention to become pregnant during the study
- Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- Not anticipating any planned changes in lifestyle for the duration of the study
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02292303
Start Date
October 1 2014
End Date
February 1 2015
Last Update
June 12 2018
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