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Recruiting NCT06851130

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

No phase Interventional Iron Deficiency Without Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ferrous sulfate 80 mg, ferrous sulfate 160 mg.
Who it may be relevant to
Registry conditions: Iron Deficiency Without Anemia. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin following the administration of a daily iron dose for two months.

Interventions

  • Dietary supplement ferrous sulfate 80 mg
    1 tablet per day
  • Dietary supplement ferrous sulfate 160 mg
    2 tablets per day

Primary outcome measures

  • Serum ferritin [Time frame: Study day 31]
  • Serum ferritin [Time frame: Study day 37]
  • Serum ferritin [Time frame: Study day 68]
  • Serum ferritin [Time frame: Study day 74]
Secondary outcome measures (12)
  • alpha(1)-acid-glycoprotein [Time frame: Study day 1]
  • Serum ferritin [Time frame: Study day 30]
  • Serum ferritin [Time frame: Study day 67]
  • Serum ferritin [Time frame: Study day 20]
  • Serum ferritin [Time frame: Study day 36]
  • Serum ferritin [Time frame: Study day 57]
  • Serum ferritin [Time frame: Study day 72]
  • Serum ferritin [Time frame: Study day 71]
  • Serum ferritin [Time frame: Study day 70]
  • Serum ferritin [Time frame: Study day 69]
  • Serum ferritin [Time frame: Study day 73]
  • Serum ferritin [Time frame: Study day 47]

Eligibility criteria

Inclusion criteria

  • Low iron stores (SF levels < 30 µg/L),
  • no anemia (Hb > 120 g/L)
  • no inflammation (CRP < 5 mg/L)
  • 18 to 45 years old.
  • Body weight <70 kg
  • Normal body Mass Index (18.5-26.5 kg/m2)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 1 center
  • Laboratory of Nutrition and Metabolic Epigenetics — Zurich

Identifiers

NCT: NCT06851130 · INFER Study 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗