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Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Zinc, Citric Acid/Trisodium Citrate and EDTA (MM_Rice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714075
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
University for Development Studies, Tamale, Ghana
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency and/or Anemia Other: Ferric Pyrophosphate and Zinc Oxide Other: Ferric Pyrophosphate and Zinc Sulphate Other: Ferric Pyrophosphate, ZnO, Citric Acid and Trisodium Citrate Other: Ferric Pyrophosphate, ZnSO4, CA/TSC Other: Ferric Pyrophosphate, ZnO, CA, EDTA Other: Ferrous Sulphate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Different Zinc Compounds, Citric Acid/Trisodium Citrate and Sodium EDTA
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Iron fortified rice
Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Other: Ferric Pyrophosphate and Zinc Oxide
Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO) and micronutrients

Other: Ferric Pyrophosphate and Zinc Sulphate
Extruded rice fortified with Ferric Pyrophosphate, Zinc Sulphate (ZnSO4) and micronutrients

Other: Ferric Pyrophosphate, ZnO, Citric Acid and Trisodium Citrate
Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO), Citric Acid (CA) and Trisodium Citrate (TSC) and micronutrients

Other: Ferric Pyrophosphate, ZnSO4, CA/TSC
Extruded rice fortified with Ferric Pyrophosphate, ZnSO4, CA/TSC and micronutrients

Other: Ferric Pyrophosphate, ZnO, CA, EDTA
Extruded rice fortified with Ferric Pyrophosphate, ZnO, CA, EDTA and micronutrients

Other: Ferrous Sulphate
Extruded rice fortified with micronutrients, Ferrous Sulphate solution will be added at consumption




Primary Outcome Measures :
  1. Fractional iron absorption [ Time Frame: baseline, 6 weeks, 11 weeks ]
    Change from baseline in the isotopic ratio of iron in blood at week 6 and 11after the administration of test meal including iron isotopes.


Secondary Outcome Measures :
  1. Hemoglobin [ Time Frame: Baseline, Week 6, Week 11 ]
    Measurements from blood will be given in mg/l.

  2. Plasma Ferritin [ Time Frame: Baseline, Week 6, Week 11 ]
    Measurements from blood will be given in mg/l.

  3. C-reactive protein [ Time Frame: Baseline, Week 6, Week 11 ]
    Measurements from blood will be given in mg/l.

  4. Zinc protoporphyrin measurement as zinc to heme ratio [ Time Frame: Baseline, Week 6, Week 11 ]
  5. Soluble Transferrin receptor in mg/l [ Time Frame: Baseline, Week 6, Week 11 ]
  6. Alpha amino glycoprotein in mg/l [ Time Frame: Baseline, Week 6, Week 11 ]


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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714075


Locations
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Ghana
University for Development Sciences
Tamale, Northern Region, Ghana, 1883
Switzerland
Swiss Federal Institute of Technology (ETH)
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
University for Development Studies, Tamale, Ghana
Investigators
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Principal Investigator: Michael B Zimmermann, Prof. Dr. Swiss FIT
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02714075    
Other Study ID Numbers: MM_Rice
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Zinc
Iron
Zinc Sulfate
Zinc Oxide
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents