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

Iron Deficiency (Without Anemia) Clinical Trial

— PCLDIT  

Official title:

Randomised, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869422
• Other study ID #: LowDoseIronVsPlacebo
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Iron Deficiency (Without Anemia)

Intervention

Dietary Supplement:
• Iron
90 ± 5 days of daily oral iron supplementation.

Other:
• Placebo
90 ± 5 days of daily oral placebo intake.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint	Incidence of adverse events during 3 months under low dose iron supplementation and placebo treatment.	90 ± 5 days
Primary	Serum-ferritin change	significant change of serum-ferritin under supplementation	90 ± 5 days
Secondary	Blood Pressure	change of blood pressure (systolic and diastolic blood pressure)	90 ± 5 days
Secondary	Blood Sugar	change of blood sugar levels	90 ± 5 days
Secondary	Lipid Status	change of lipid status (total cholesterol, HDL, LDL, triglycerides)	90 ± 5 days