NCT05580783

Brief Summary

Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. With this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

November 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

October 6, 2022

Last Update Submit

November 21, 2023

Conditions

Iron-deficiency

Keywords

AnemiaMicronutrientsIronTrace elementsMenstruationHormones

Outcome Measures

Primary Outcomes (1)

  • Fractional iron absorption (%)

    Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the labelled test meals.

    Day 2, 18, 22, 26 and 40

Secondary Outcomes (11)

  • Hemoglobin concentration (g/L)

    Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40

  • Serum ferritin (microg/L)

    Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

  • Serum transferrin receptor (mg/L)

    Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

  • Serum iron (microg/mL)

    Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

  • Serum hepcidin (nmol/L)

    Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

  • +6 more secondary outcomes

Study Arms (3)

Experimental 54Fe

EXPERIMENTAL

Participants will receive 54Fe at two time points throughout their menstrual cycle.

Other: Test meal labelled with 54Fe

Experimental 57Fe

EXPERIMENTAL

Participants will receive 57Fe at two time points throughout their menstrual cycle.

Other: Test meal labelled with 57Fe

Experimental 58Fe

EXPERIMENTAL

Participants will receive 58Fe at two time points throughout their menstrual cycle.

Other: Test meal labelled with 58Fe

Interventions

Test meal labelled with 54FeOTHER

Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe

Experimental 54Fe
Test meal labelled with 57FeOTHER

Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe

Experimental 57Fe
Test meal labelled with 58FeOTHER

Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe

Experimental 58Fe

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, 18-30 years old
  • Weight \<70 kg
  • Normal body mass index (18.5 - 25kg/m2)
  • Regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months)
  • Depleted iron stores (serum ferritin ≤ 30 µg/L)
  • Signed informed consent
  • Able to read and understand English

You may not qualify if:

  • Use of hormonal contraceptives within a 3-month recall period
  • Anemia (hemoglobin \< 117 g/L)
  • Any known major 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)
  • Women with severe menstrual cramps that would prevent them from attending study meetings during menstruation (judged by the women)
  • Consumption of iron-containing supplements within 1 month prior to the start of study
  • Known difficulties with blood sampling
  • Pregnancy (serum human chorionic gonadotropin (hCG) \< 5 mIU/mL)
  • Current smoking (\>1 cigarette per week over a 1-month recall period)
  • Women who are planning to get pregnant within the study period, as this would affect iron metabolism and subsequent study measurements.
  • Inability to follow the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 14, 2022

Study Start

November 5, 2022

Primary Completion

January 6, 2023

Study Completion

May 15, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)