Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Zinc, Citric Acid/Trisodium Citrate and EDTA
MM_Rice
1 other identifier
interventional
30
2 countries
2
Brief Summary
Rice can only be fortified with ferric pyrophosphate (FePP), which is of low bioavailability in human subjects. Compounds such as citric acid/trisodium citrate (CA/TSC) or sodium ethylene-diamine tetraacetic-acid (EDTA) could serve as absorption enhancers. Recent findings from single meal studies indicate CA/TSC to have an enhancing effect on iron absorption from FePP-fortified rice. In contrast, ZnO has been suggested to have detrimental effects. Furthermore, in vitro findings suggest an increased iron solubility from iron and EDTA-co-fortified rice - but the bioavailability in humans remains to be investigated. These effects should thus be investigated in 'real-life' conditions, when fortified rice is implemented in a complete diet administered throughout several days in a target population for a rice fortification program. Objective: To assess iron absorption from the diet from different iron fortified rice formulations in iron deficient anaemic children. The investigators aim to conduct an iron absorption study in 30 Ghanaian school-age children investigating different fortification approaches in a multiple meal randomized, cross over study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
2 active sites
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
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 7, 2016
December 1, 2016
2 months
March 10, 2016
December 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Fractional iron absorption
Change from baseline in the isotopic ratio of iron in blood at week 6 and 11after the administration of test meal including iron isotopes.
baseline, 6 weeks, 11 weeks
Secondary Outcomes (6)
Hemoglobin
Baseline, Week 6, Week 11
Plasma Ferritin
Baseline, Week 6, Week 11
C-reactive protein
Baseline, Week 6, Week 11
Zinc protoporphyrin measurement as zinc to heme ratio
Baseline, Week 6, Week 11
Soluble Transferrin receptor in mg/l
Baseline, Week 6, Week 11
- +1 more secondary outcomes
Study Arms (1)
Iron fortified rice
EXPERIMENTALAdministration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Interventions
Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO) and micronutrients
Extruded rice fortified with Ferric Pyrophosphate, Zinc Sulphate (ZnSO4) and micronutrients
Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO), Citric Acid (CA) and Trisodium Citrate (TSC) and micronutrients
Extruded rice fortified with Ferric Pyrophosphate, ZnSO4, CA/TSC and micronutrients
Extruded rice fortified with Ferric Pyrophosphate, ZnO, CA, EDTA and micronutrients
Extruded rice fortified with micronutrients, Ferrous Sulphate solution will be added at consumption
Eligibility Criteria
You may qualify if:
- Iron deficient and/or anemic as per definition;
- Read and signed informed consent form by the caregiver (or has been read out to the caregiver in case of illiteracy);
- Absence of any metabolic-, gastrointestinal or chronic diseases.
You may not qualify if:
- Severe underweight (Z-score weight-for-age \<-3);
- Severe wasting (Z-score weight-for-height\<-3);
- Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol;
- Participants taking part in other studies requiring the drawing of blood;
- Participants who will not be able to comply with the protocol (e.g. plan to move, planned absence, etc.);
- Regular intake (\>2 days) of iron-containing mineral and vitamin supplements within the last 2 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University for Development Sciences
Tamale, Northern Region, 1883, Ghana
Swiss Federal Institute of Technology (ETH)
Zurich, Canton of Zurich, 8092, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Zimmermann, Prof. Dr.
Swiss FIT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 21, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 7, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share