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OpenTrials
Completed

NCT Number: NCT04636060

Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women

Iron deficiency is common in Switzerland and the main reason for anaemia. Nearly one in five premenopausal women suffers from iron deficiency. Low iron intake, reduced iron resorption or loss of blood are the main cause for iron deficiency. Symptoms of iron deficiency, for example fatigue, weakness, headache or exercise intolerance are primarily due to anaemia, but the same symptoms may also be present in non-anaemic patients with low serum ferritin. Consequently it is important to detect and treat non-anaemic iron deficiency. Common side effects of oral iron supplementation are primarily gastrointestinal symptoms like nausea, vomiting, diarrhea or abdominal pain. There is a positive correlation between appearance of gastrointestinal symptoms and administered iron dose. To date, only few studies have investigated effectiveness of low-dose iron supplementation in different target groups. The aim of this study is to investigate if low dose iron supplementation with 12mg iron per day for 8 weeks is sufficient to increase serum ferritin levels into a normal range in healthy premenopausal women suffering from non-anaemic iron deficiency

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Key information

Conditions

Iron Deficiency (Without Anemia) Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent as documented by signature
  • Female gender
  • Premenopausal
  • Age > 18 years
  • Regular menstrual cycle
  • BMI in normal range (18-25 kg/m²)
  • Serum-ferritin <30ng/ml
  • No anaemia
  • symptomatic iron deficiency in the past
  • No intake of dietary supplements

Exclusion criteria

  • Intake of dietary supplements
  • Pregnancy
  • Hypermenorrhea
  • Anaemia
  • Serum-ferritin >30ng/ml
  • BMI <18 kg/m² or >25 kg/m²
  • chronic inflammatory diseases (e.g. colitis)
  • Hypersensitivity to iron-supplements
  • psychiatric disorder

Treatment and study plan

Eisen

Dietary Supplement

Treatment with low-dose iron in the form of tablets containing 6mg of iron. Treatment consists of twice-daily oral administration of iron-tablets for 8 weeks in total.

Primary outcomes

  1. Increase of serum ferritin concentration under iron supplementation

    Time frame: 8 weeks

    significant increase of serum-ferritin concentration after 8 weeks of low-dose iron-supplementation

Secondary outcomes

  1. Side-effects of treatment

    Time frame: 8 weeks

    Adverse events will be assessed on a report form after 8 weeks

  2. Serum hepcidin concentration

    Time frame: 8 weeks

    no increase in hepcidin-production during low-dose iron supplementation

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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