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Trial record 87 of 380 for:    FERRIC CATION

Iron Bioavailability of High Surface Area Ferric Phosphate (HiFe)

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: NCT03660462
Recruitment Status : Active, not recruiting
First Posted : September 6, 2018
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Brief Summary:
The primary objective of this study is to compare iron absorption of high surface area ferric phosphate with that of ferrous sulfate and bulk ferric phosphate in a rice-based meal in non-pregnant women.

Condition or disease Intervention/treatment Phase
Iron-deficiency Dietary Supplement: FeSO4 fortified rice test meal Dietary Supplement: FePO4 fortified rice test meal Dietary Supplement: HiFePO4 1 fortified rice test meal Dietary Supplement: HiFePO4 2 fortified rice test meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: FeSO4 fortified rice test meal Dietary Supplement: FeSO4 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)

Experimental: FePO4 fortified rice test meal Dietary Supplement: FePO4 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)

Experimental: HiFePO4 1 fortified rice test meal Dietary Supplement: HiFePO4 1 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)

Experimental: HiFePO4 2 fortified rice test meal Dietary Supplement: HiFePO4 2 fortified rice test meal
Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)




Primary Outcome Measures :
  1. Fractional iron absorption [ Time Frame: Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31) ]
    Iron absorption will be determined by measurement of the isotopic ratio change from the 4 different types of iron vehicles (FeSO4 fortified rice test meal, FePO4 fortified rice test meal, HiFePO4 1 fortified rice test meal, HiFePO4 2 fortified rice test meal).



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of reproductive age (18 to 49 years) in Thailand
  • BMI < 23 kg/m2
  • Body weight < 65 kg
  • Mildly anaemic to normocythemic (Hb 80-110 g/L)
  • Ferritin < 25 µg/L
  • Not pregnant (confirmed by pregnancy test stripe) or lactating
  • No inflammation (CRP < 5 mg/L)
  • Having provided written informed consent

Exclusion Criteria:

  • Haemoglobinopathies (except heterozygosity for haemoglobin E and alpha-thalassemia 1)
  • Coeliac disease or other chronic diseases of malabsorption that could influence iron absorption or metabolism
  • Blood donation or significant blood loss due to surgery or accident < 4 months before start of the study
  • Consumption of vitamin or mineral supplements 2 weeks before start of the study
  • Regular use of medication (except oral contraceptives), that influences iron absorption
  • Chronic inflammatory disease
  • Smoking

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): NCT03660462


Locations
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Thailand
Mahidol University
Salaya, Nakhon Pathom, Thailand, 73170
Sponsors and Collaborators
Swiss Federal Institute of Technology
Mahidol University

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Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03660462     History of Changes
Other Study ID Numbers: HiFe
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics