Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05869422 | NOT YET RECRUITING | Iron Deficiency (Without Anemia)

Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
Sponsor:

University of Zurich

Brief Summary:

The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.

Condition or disease

Iron Deficiency (Without Anemia)

Intervention/treatment

Iron

Placebo

Phase

NA

Detailed Description:

The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 3 months (90 days), the other one will get two placebo tablet for 3 months, accordingly.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Randomised, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
Actual Study Start Date : 2023-10
Estimated Primary Completion Date : 2024-04
Estimated Study Completion Date : 2024-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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 ≤30µg/l
  • * no anaemia (Hemoglobin ≥117g/l)
  • * no intake of dietary supplements containing iron (last 4 weeks)
  • * the participant is linguistically and cognitively able to understand the study procedure
Exclusion Criteria
  • * Current pregnancy
  • * breastfeeding
  • * hypermenorrhea (more than 5 unties/tampons per day)
  • * chronic inflammatory diseases (e.g. colitis)
  • * psychiatric disorders
  • * chronic kidney disease (creatinine \>80 µmol/l)
  • * liver disease (ALT \>35 U/l)
  • * increased CRP (\>5mg/l)
  • * Hypo- or Hyperthyroidism (TSH not between 0.16 - 4.25 mU/l)
  • * hypersensitivity to iron-supplements
  • * intake of medicines that interact with oral iron supplementation (e.g. PPI)
Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

Location Details

NCT05869422

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found