Using Stable Iron Isotopic Techniques and Serum Hepcidin Profiles to Optimize Iron Supplementation

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Iron Deficiency Anemia
Anemia
Iron Deficiency

Treatments

Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)

Study type

Interventional

Funder types

Other

Identifiers

NCT01785407
EK 2012-N-44

Details and patient eligibility

About

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).

Full description

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: 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). 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 40, 80, 160 and 240 mg in either single or as two consecutive dosages with stable iron isotopes 54Fe, 57Fe, 58Fe in form of 4 mg of iron sulfate (FeSO4). Prior administration blood samples will be collected at 8:00, 12:00 and 16:00 to monitor sHep and iron status markers, these measurements will be repeated on the days of supplement administration. On the following days, sHep will be measured at 8:00 to quantify the duration of the iron induced hepcidin rise. In the second week, subjects receiving a single Fe dose on week 1 will receive two consecutive dosages and vice versa, while the same sampling scheme as in week one will be applied. On day 23, a last blood sample will be collected and iron incorporation of stable isotopic labels will be measured from the different dosages administered. 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.

Enrollment

25 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 4 patient groups

80 mg FeSO4
Active Comparator group
Treatment:
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)
40 mg FeSO4
Active Comparator group
Description:
40 mg FeSO4
Treatment:
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)
160 mg FeSO4
Active Comparator group
Treatment:
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)
240 mg FeSO4
Active Comparator group
Treatment:
Dietary Supplement: Iron Supplement (Ferrous Sulfate Dried)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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