The Optimization of Bioavailability From Iron Supplements: Study 1

NCT ID: NCT02175888

Last Updated: 2017-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-01-31

Brief Summary

Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.

The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.

Conditions

Iron Deficiency; Anemia; Iron Deficiency Anemia

Keywords

Iron bio availability; Hepcidin; Iron absorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral iron supplement every day for 14 days

Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days

Group Type: EXPERIMENTAL

Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days

Intervention Type: DIETARY_SUPPLEMENT

Oral iron supplement every second day for 28 days

Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days

Group Type: ACTIVE_COMPARATOR

Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days

Intervention Type: DIETARY_SUPPLEMENT

Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Female, 18 to 45 years old,
• Serum ferritin levels </=25 µg/L,
• Normal body Mass Index (18.5-26.5 kg/m2),
• Body weight <80 kg,
• Signed informed consent

Exclusion Criteria

• Anaemia (Hb < 8.0 g/dL),
• Elevated c-reactive protein or alpha1-glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively,
• Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
• Continuous/long-term use of medication during the whole studies (except for contraceptives),
• Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration,
• Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months,
• Earlier participation in a study using stable iron isotopes,
• Known hypersensitivity or allergy to iron supplements,
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the studies,
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present studies,
• Enrolment of the investigator, his/her family members, employees and other dependent persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego Moretti, PhD

Role: PRINCIPAL_INVESTIGATOR

Human Nutrition Laboratory, ETH Zurich

Locations

Human Nutrition Laboratory

Zurich, , Switzerland

Countries

Switzerland

References

Lazrak M, El Kari K, Stoffel NU, Elammari L, Al-Jawaldeh A, Loechl CU, Yahyane A, Barkat A, Zimmermann MB, Aguenaou H. Tea Consumption Reduces Iron Bioavailability from NaFeEDTA in Nonanemic Women and Women with Iron Deficiency Anemia: Stable Iron Isotope Studies in Morocco. J Nutr. 2021 Sep 4;151(9):2714-2720. doi: 10.1093/jn/nxab159.

Reference Type: DERIVED

PMID: 34038558 (View on PubMed)

Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.

Reference Type: DERIVED

PMID: 29032957 (View on PubMed)

Other Identifiers

FeSupp_Hep-1

Identifier Type: -

Identifier Source: org_study_id