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

NCT04636060 | Completed

• 1 other identifier: LowdoseIron
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency (Without Anemia)

Outcome Measures

Primary Outcomes (1)

• Increase of serum ferritin concentration under iron supplementation

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

  8 weeks

Secondary Outcomes (2)

• Side-effects of treatment

  8 weeks

• Serum hepcidin concentration

  8 weeks

Study Arms (1)

Iron-treatment group

EXPERIMENTAL

Dietary Supplement: Eisen

Interventions

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.

Iron-treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Simic S, Karczewski M, Klapdor S, Nowak A, Schubert M, Moretti D, Swinkels DW, Beuschlein F, Saleh L, Suter P, Krayenbuehl PA. Effectiveness of low-dose iron treatment in non-anaemic iron-deficient women: a prospective open-label single-arm trial. Swiss Med Wkly. 2023 May 25;153:40079. doi: 10.57187/smw.2023.40079.

  PMID: 37229775 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Iron, Dietary

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Iron Compounds; Inorganic Chemicals

Study Officials

• Pierre-Alexandre Krayenbühl

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 19, 2020
• Study Start: July 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

CH (1)