NCT01785407

Brief Summary

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: it may be in the range of 24 to 96 hr. 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 the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2) Compare the bioavailability of a single dose to iron supplements consumed one after the other (two dosages).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

February 1, 2013

Last Update Submit

November 8, 2013

Conditions

Iron DeficiencyAnemiaIron Deficiency Anemia

Keywords

Iron bio availabilityHepcidinIron absorption

Outcome Measures

Primary Outcomes (1)

  • Iron bio-availability from Oral Iron Supplements (%)

    Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood 14 days after administration will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).

    three weeks

Secondary Outcomes (1)

  • Hepcidin

    three weeks

Study Arms (4)

80 mg FeSO4

ACTIVE COMPARATOR
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)

40 mg FeSO4

ACTIVE COMPARATOR

40 mg FeSO4

Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)

160 mg FeSO4

ACTIVE COMPARATOR
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)

240 mg FeSO4

ACTIVE COMPARATOR
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)

Interventions

Iron Supplement (Ferrous Sulfate Dried)DIETARY_SUPPLEMENT

Iron supplements of varying concentration will be administered to the four groups in the study. Iron bioavailability from the supplements will be assessed.

Also known as: Ferrous Sulfate (dried)
160 mg FeSO4240 mg FeSO440 mg FeSO480 mg FeSO4

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 17-25
  • No anemia
  • Low iron stores defined as Serum Ferritin \< 20 micrograms/L
  • No blood donation in in the last 4 months
  • No intake of vitamin and mineral supplements 2 weeks prior and during the study

You may not qualify if:

  • Chronic, metabolic, gastrointestinal diseases
  • Taking medication
  • Participation to clinical trials in the last 30 days.
  • Previous participation to iron bio availability studies with stable isotopic labels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Location

Related Publications (2)

  • Zimmermann MB, Hurrell RF. Nutritional iron deficiency. Lancet. 2007 Aug 11;370(9586):511-20. doi: 10.1016/S0140-6736(07)61235-5.

    PMID: 17693180BACKGROUND

  • 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: 26289639DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemiaAnemia, Iron-Deficiency

Interventions

Iron-Dextran Complexferrous sulfateDesiccation

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia, Hypochromic

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydratesChemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Officials

  • Diego Moretti, PhD

    ETH Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

CH(1)