NCT01633450

Brief Summary

One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

June 29, 2012

Last Update Submit

June 6, 2013

Conditions

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.

    33 days

Study Arms (2)

Zinc biofortified rice

EXPERIMENTAL
Other: Zinc biofortified rice

Rice extrinsically fortified with zinc

ACTIVE COMPARATOR
Other: Rice extrinsically fortified with zinc

Interventions

1.12 mg zinc per meal

Zinc biofortified rice

1.12 mg zinc per meal

Rice extrinsically fortified with zinc

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)
  • 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 - 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, Switzerland

Location

Related Publications (1)

  • Brnic M, Wegmuller R, Melse-Boonstra A, Stomph T, Zeder C, Tay FM, Hurrell RF. Zinc Absorption by Adults Is Similar from Intrinsically Labeled Zinc-Biofortified Rice and from Rice Fortified with Labeled Zinc Sulfate. J Nutr. 2016 Jan;146(1):76-80. doi: 10.3945/jn.115.213421. Epub 2015 Dec 16.

MeSH Terms

Interventions

Zinc

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 4, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations