NCT01576627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

April 4, 2012

Last Update Submit

January 3, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Fractional absorption of zinc

    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.

    61 days

Study Arms (3)

zinc citrate

EXPERIMENTAL
Dietary Supplement: zinc citrate

zinc gluconate

ACTIVE COMPARATOR
Dietary Supplement: Zinc Gluconate

zinc oxide

ACTIVE COMPARATOR
Dietary Supplement: Zinc oxide

Interventions

zinc citrateDIETARY_SUPPLEMENT

10 mg of zinc as either zinc citrate

zinc citrate
Zinc GluconateDIETARY_SUPPLEMENT

10 mg of zinc as either zinc gluconate

zinc gluconate
Zinc oxideDIETARY_SUPPLEMENT

10 mg of zinc as either zinc oxide

zinc oxide

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

  • Wegmuller R, Tay F, Zeder C, Brnic M, Hurrell RF. Zinc absorption by young adults from supplemental zinc citrate is comparable with that from zinc gluconate and higher than from zinc oxide. J Nutr. 2014 Feb;144(2):132-6. doi: 10.3945/jn.113.181487. Epub 2013 Nov 20.

    PMID: 24259556DERIVED

MeSH Terms

Interventions

gluconic acidZinc Oxide

Intervention Hierarchy (Ancestors)

OxidesOxygen CompoundsInorganic ChemicalsZinc Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 12, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

CH(1)