Iron Bioavailability of High Surface Area Ferric Phosphate

NCT03660462 | Completed

• 1 other identifier: HiFe
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  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).

  Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31)

Study Arms (4)

FeSO4 fortified rice test meal

ACTIVE COMPARATOR

Dietary Supplement: FeSO4 fortified rice test meal

FePO4 fortified rice test meal

EXPERIMENTAL

Dietary Supplement: FePO4 fortified rice test meal

HiFePO4 1 fortified rice test meal

EXPERIMENTAL

Dietary Supplement: HiFePO4 1 fortified rice test meal

HiFePO4 2 fortified rice test meal

EXPERIMENTAL

Dietary Supplement: HiFePO4 2 fortified rice test meal

Interventions

FeSO4 fortified rice test meal DIETARY_SUPPLEMENT

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

FeSO4 fortified rice test meal

FePO4 fortified rice test meal DIETARY_SUPPLEMENT

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

FePO4 fortified rice test meal

HiFePO4 1 fortified rice test meal DIETARY_SUPPLEMENT

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

HiFePO4 1 fortified rice test meal

HiFePO4 2 fortified rice test meal DIETARY_SUPPLEMENT

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

HiFePO4 2 fortified rice test meal

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Mahidol University: collaborator

Study Sites (1)

Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: November 21, 2018
• Primary Completion: June 19, 2019
• Study Completion: July 19, 2019
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)