Status:
COMPLETED
Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
Lead Sponsor:
Isabelle Herter-Aeberli
Collaborating Sponsors:
Burgerstein Vitamine
Conditions:
Iron-deficiency
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. In a recent iron absorption study in adult women with low iron stores in our lab (publicati...
Detailed Description
Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nu...
Eligibility Criteria
Inclusion
- Female, 18 to 45 years old
- SF levels \<30 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, inject-able, 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
- Enrollment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03762148
Start Date
April 1 2019
End Date
June 11 2019
Last Update
July 25 2019
Active Locations (1)
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1
Human Nutrition Laboratory, ETH Zurich
Zurich, Switzerland, 8092