PCLDIT: Placebo-controlled Low-dose Iron Therapy
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. They 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, we would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, we would like to show the reduction of side effects, as well as an increase of low blood pressure to normal blood pressure. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 8 weeks, the other one will get two placebo tablet for 8 weeks, accordingly.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Other: Placebo
8 weeks of daily oral placebo intake.
|
| Experimental: Low Dose Iron
|
Dietary Supplement: Iron
8 weeks of daily oral iron therapy.
|
Outcome Measures
Primary Outcome Measures
- Serum-ferritin increase [8 weeks]
significant increase of serum-ferritin under treatment
Secondary Outcome Measures
- Adverse events [8 weeks]
tolerance of a low-dose iron treatment
- Blood Pressure [8 weeks]
increase of low blood pressure
Eligibility Criteria
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Zurich
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LowDoseIronVsPlacebo