The Optimization of Iron Bioavailability of Supplements Using Hepcidin Levels in Humans

NCT02050932 | Completed

• 1 other identifier: EK 2013-N-41
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose but the duration of the increase is uncertain: In a recent study conducted in our laboratory it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep determines the absorption of further doses of oral iron. Is there a threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding of this relationship would be valuable to design more effective and safer OIS regimens. Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron supplement dosages given at different times of the day (Study 2). Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic subjects will be excluded from the study. Thirty two subjects will be included with serum ferritin \<20 µg/L, C-reactive protein \<5 mg/L and Hemoglobin \>117 g/L. Subjects will be randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1 (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes 54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be collected to monitor sHep and iron status markers. Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for better understanding of the iron-hepcidin relationship and this may enable design of more effective OIS regimens.

Conditions

Iron Deficiency

Keywords

hepcidin; iron bioavailability; iron supplementation

Outcome Measures

Primary Outcomes (1)

• Iron absorption of stable isotopic tracers.

  Stable iron isotopes will be administered under standardized conditions and close supervision. Iron absorption will be calculated from the shift in the normal isotopic abundance in Red blood cells 14 days after test meal incorporation.

  14 days

Secondary Outcomes (3)

• Iron status

  14 days

• Inflammatory status

  14 days

• Hepcidin level

  14 days

Study Arms (1)

Iron absorption assessement

EXPERIMENTAL

60 mg Fe as FeSO4 with stable isotopic labels participants will receive at different times of the day (total of three dosages) and follow a standardized diet scheme. Subjects will act as their own controls during the study

Dietary Supplement: 60 mg Fe as FeSO4 with stable isotopic labels

Interventions

60 mg Fe as FeSO4 with stable isotopic labels DIETARY_SUPPLEMENT

Subjects will receive FeSo4 supplements labeled with stable isotopic labels (54Fe, 57Fe, 58Fe) and iron absorption will be measured for each administration

Iron absorption assessement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy, no blood donation in the last 4 months, not pregnant, not lactating, not taking vitamin and mineral supplements 2 weeks prior the study, non smoker, weight \<65 Kg, BMI between 18 and 25.
• No anemia (defined as 11.7 g/dl, Serum ferritin level \< 20 microgram/L).

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Zürich, Laboratory of Human Nutrition

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

• Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.

  PMID: 26289639 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Diego Moretti, PhD

  ETH Zürich, Laboratory of Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: January 31, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

CH (1)