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Iron Absorption in Haiti

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ClinicalTrials.gov Identifier: NCT02096250
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
International Atomic Energy Agency
Information provided by (Responsible Party):
Isabelle Aeberli, Swiss Federal Institute of Technology

Brief Summary:
The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.

Condition or disease Intervention/treatment Phase
Iron Deficiency Other: NaFeEDTA Other: Ferrous fumarate Other: NaFeEDTA + ferrous fumarate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Iron Absorption From Wheat Flour in Haiti
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: NaFeEDTA
NaFeEDTA
Other: NaFeEDTA
Experimental: Ferrous fumarate
Ferrous fumarate
Other: Ferrous fumarate
Experimental: NaFeEDTA + ferrous fumarate
NaFeEDTA + ferrous fumarate
Other: NaFeEDTA + ferrous fumarate



Primary Outcome Measures :
  1. Iron absorption [ Time Frame: 14 days after test meal consumption ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Mother-child pairs will be recruited!

Inclusion criteria for mothers :

  • Women of reproductive age (18 to 45 years)
  • Generally healthy
  • Consenting to study participation

Exclusion criteria for mothers :

  • Pregnancy or lactation
  • Weight >65 kg
  • Chronic illnesses which may influence iron absorption
  • Severe anemia (Hb<10 g/dl)

Inclusion criteria for children:

  • Age 4 years +/- 12 months
  • Generally healthy

Exclusion criteria for children :

  • Severe anemia (Hb<10 g/dl)
  • Weight for height < -2 Z scores (wasting)
  • Height of age < -2 Z score (stunting)

Furthermore, the following exclusion criteria apply to both mothers and children :

  • Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)
  • Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)
  • Allergies or intolerances relevant to the test meal (gluten)
  • Blood donation or major blood losses during the 2 months prior to the study
  • Illness during the 4 weeks prior to the study (will be judged by investigator)

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): NCT02096250


Locations
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Haiti
Ministère de la Santé Publique et de la Population
Port au Prince, Haiti
Sponsors and Collaborators
Swiss Federal Institute of Technology
International Atomic Energy Agency
Investigators
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Principal Investigator: Isabelle Aeberli, PhD ETH Zurich (Switzerland)

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Responsible Party: Isabelle Aeberli, PhD, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02096250     History of Changes
Other Study ID Numbers: EK 2013-N43
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferrous fumarate
Fe(III)-EDTA
Edetic Acid
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Hematinics