Zinc Absorption From Zinc Citrate, Zinc Gluconate and Zinc Oxide

• Sponsor: Prof. Michael B. Zimmermann (Other)
• Overall Status: Completed
• CT.gov ID: NCT01576627
• Collaborator: University of Zurich (Other)
• Enrollment: 15
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The goal of this trial is to evaluate zinc citrate, a zinc compound with promising sensory properties and a high zinc content, as an alternative zinc compound to be used for supplementation or food fortification. The bioavailability of zinc citrate given as a supplement to young Swiss adults will be assessed and compared to the bioavailability of the commonly used zinc compounds zinc gluconate and zinc oxide.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: zinc citrate; Dietary Supplement: Zinc Gluconate; Dietary Supplement: Zinc oxide	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Zinc Absorption From Zinc Supplements Comparing Zinc Citrate to Zinc Gluconate and Zinc Oxide in Young Adults
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zinc citrate	Dietary Supplement: zinc citrate; 10 mg of zinc as either zinc citrate
Active Comparator: zinc gluconate	Dietary Supplement: Zinc Gluconate; 10 mg of zinc as either zinc gluconate
Active Comparator: zinc oxide	Dietary Supplement: Zinc oxide; 10 mg of zinc as either zinc oxide

Outcome Measures

Primary Outcome Measures

1. Fractional absorption of zinc [61 days]

   Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female of 18 to 45 years old

• Body Mass Index in the range of 19 to 25

• No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

• Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)

• Long-term medication during the whole study (except for contraceptives)

• Vegans

• Pregnancy

• Lactation

• Intention to become pregnant during the course of the study

• Lack of safe contraception

• Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test supplement administration

• Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ETH Zurich	Zurich		Switzerland	8092

Sponsors and Collaborators

• Prof. Michael B. Zimmermann
• University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT01576627
• Other Study ID Numbers: HNL/CTC11-12
• First Posted: Apr 12, 2012
• Last Update Posted: Jan 4, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Zinc; Zinc Oxide

Study Results

No Results Posted as of Jan 4, 2013