Status:
COMPLETED
Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Burgerstein Vitamine
Conditions:
Iron-deficiency
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Rationale: According to the WHO, iron deficiency is still the most common and widespread nutritional disorder in the world. Current iron supplements have limitations in terms of bioavailability and t...
Detailed Description
Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. It does not only affect large numbers of women and children in the developing world, but als...
Eligibility Criteria
Inclusion
- Female, 18 to 45 years old
- SF levels \<20 µg/L
- Normal body Mass Index (18.5-24.9 kg/m2)
- Body weight \<70 kg
- Signed informed consent
Exclusion
- Severe anaemia (Hb \< 80 g/L)
- Elevated CRP \>10.0 mg/L
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole studies (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Difficulties with blood sampling
- Use of antibiotics over the past month
- Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
- Women who are pregnant or breast feeding
- Women who intend become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -
- Smokers (\> 1 cigarette per week)
- Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03325270
Start Date
January 10 2018
End Date
April 28 2018
Last Update
January 16 2019
Active Locations (1)
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1
ETH Zurich
Zurich, Switzerland, 8092