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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