NCT02572128

Brief Summary

The investigators studies will compare iron, respectively iron and zinc bioavailability from fortified rice produced from different fortification techniques using stable isotopic labels. Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in Study 2 the iron and zinc bioavailability from rice using one coating technique and hot extrusion will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

April 15, 2015

Last Update Submit

July 11, 2016

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (2)

  • Study 1: Fractional iron absorption;

    Fractional iron (Study 1 and 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected blood (for iron determination) samples. The iron absorption will be assessed from blood samples collected 14 or 15 days after meal administration. Iron isotope ratios will be determined by mass spectrometry. Total absorbed iron: measurement unit = mg; Fractional absorbed zinc: measurement unit = %

    6 months

  • Study 2: Additionally fractional Zinc absorption

    Fractional zinc (Study 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected urine (for zinc determination) samples. The zinc absorption will be assessed from urine samples collected 4 days after meal administration. Zinc isotope ratios will be determined by mass spectrometry. Total absorbed zinc: measurement unit = mg; Fractional absorbed zinc: measurement unit = %

    3 months

Secondary Outcomes (4)

  • Hemoglobin

    6 months

  • Plasma Ferritin

    6 months

  • C- Reactive Protein

    6 months

  • Plasma Zinc

    6 months

Study Arms (2)

Study 1

EXPERIMENTAL

Iron fortified rice hot or cold extruded.

Other: Fortified rice

Study 2

EXPERIMENTAL

Iron and zinc fortified rice hot extruded or coated.

Other: Fortified rice

Interventions

Fortified riceOTHER

Study 1: Hot or cold extruded rice fortified test meals fortified with Ferric Pyrophosphate and Zinc oxide will be administered - subjects serve as their own controls. Study 2: Hot extruded rice or coated rice fortified with Ferric Pyrophosphate and Zinc Oxide will be administered. Regular rice fortified with Ferrous Sulfate (FeSO4) will act as a control in study 2.

Study 1Study 2

Eligibility Criteria

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

You may qualify if:

  • Female, 18 to 45 years old
  • Normal body Mass Index (18.5 - 25 kg/m2)
  • Body weight \< 65 kg
  • Signed informed consent

You may not qualify if:

  • Pregnancy (assessed by a pregnancy test) or intention to become pregnant during the study
  • Lactating/ Breastfeeding
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole study (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration and during the intervention time
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months and during the intervention time
  • Earlier participation in a study using Fe or Zn stable isotopes or participation in any clinical study within the last 30 days
  • Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
  • Smoking
  • Vegan diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Trials Center, University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

Location

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michael Zimmermann, Prof. Dr.

    Head of Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2015

First Posted

October 8, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CH(2)