Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women (PCLDIT)

University of Zurich (UZH)

Status: Not yet enrolling

Conditions: Iron Deficiency (Without Anemia)

Treatments: Dietary Supplement: Iron; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05869422

LowDoseIronVsPlacebo

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo tablet containing no iron

Treatment:

Other: Placebo

Low Dose Iron

Experimental group

Description:

low-dose tablet containing 6mg of iron

Treatment:

Dietary Supplement: Iron