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Completed

NCT Number: NCT03660462

Iron Bioavailability of High Surface Area Ferric Phosphate

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeSO4 fortified rice test meal

Dietary Supplement

Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)

FePO4 fortified rice test meal

Dietary Supplement

Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)

HiFePO4 1 fortified rice test meal

Dietary Supplement

Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)

HiFePO4 2 fortified rice test meal

Dietary Supplement

Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Mahidol University

Registry information

Official study title

Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women

Acronym: HiFe

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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