Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID06851130

Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women

Led by Swiss Federal Institute of Technology · Updated on 2025-05-20

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying women with iron deficiency without anemia to understand how daily oral iron doses affect serum ferritin, a key marker of the body's iron stores. The study focuses on the immediate increase in serum ferritin levels caused by iron supplements and how long this effect lasts during a two-month supplementation period. This research is important because oral iron can temporarily raise ferritin, possibly biasing assessments of iron status during treatment. Participants receive one of two daily doses of ferrous sulfate: either 80 mg or 160 mg. Each dose is taken daily for one month, followed by a 7-day break, then resumed for another month, making a total of two months of supplementation. The study is randomized and compares these two dosing schedules to evaluate their effects on serum ferritin levels over time. During the study, participants undergo multiple blood tests to measure serum ferritin, hemoglobin, C-reactive protein, and alpha(1)-acid-glycoprotein at specified days throughout the treatment and break periods. These assessments help monitor iron status, inflammation, and overall health. The primary outcome is serum ferritin measured on days 31, 37, 68, and 74. The study helps clarify how oral iron supplementation influences ferritin measurements, aiding better management of iron deficiency. Participation lasts for about two and a half months including treatment and monitoring.

CONDITIONS

Brief Title

Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Low iron stores with serum ferritin levels below 30 µg/L
  • No anemia with hemoglobin above 120 g/L
  • No inflammation with C-reactive protein below 5 mg/L
  • Female aged 18 to 45 years
  • Body weight less than 70 kg
  • Normal body mass index between 18.5 and 26.5 kg/m2
Not Eligible

You will not qualify if you...

  • Any chronic or acute disease
  • Use of mineral and vitamin supplements since screening and during the study
  • Blood transfusion, donation, or significant blood loss in the past 4 months
  • Pregnant or breastfeeding
  • Continuous or long-term medication use during the study except contraceptives
  • Therapeutic iron infusion in the past 6 months
  • Known allergy or hypersensitivity to iron supplements
  • Intention to become pregnant during the study period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 months with a 7-day break between months

Participants take oral iron supplements daily in doses of either 80 mg or 160 mg for 1 month, followed by a 7-day break, then resume the same dose for another month.

Multiple visits for assessments throughout the 2 months

Trial Site Locations

Total: 1 location

1

Laboratory of Nutrition and Metabolic Epigenetics

Zurich, Canton of Zurich, Switzerland, 8092

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Research Team

N

Nicole Stoffel, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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