Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04194567
Eligibility Criteria:
Inclusion Criteria:
* Female, 18 to 40 years old
* Body weight up to 65 kg
* Normal Body Mass Index (18.5 - 25 kg/m2)
* Signed informed consent
* Plasma ferritin \< 25 ng/ml
* Able to communicate in and comprehend English language
* Tasted and found the Ragi to be of acceptable taste and confirmed will to consume the test meals if enrolled in the study
Exclusion Criteria:
* Pregnancy (assessed by a urinary pregnancy test) / intention to become pregnant
* Lactating up to 6 weeks before study initiation
* Moderate or severe anaemia (Hb \< 9.0 g/dL)
* Elevated CRP (\> 5.0 mg/L)
* Any metabolic, gastrointestinal, kidney or chronic disease such as celiac disease, diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
* Continuous/long-term use of medication during the whole study (except for contraceptives)
* Consumption of mineral and vitamin supplements within 2 weeks prior to first meal administration
* Blood transfusion, blood donation or significant blood loss (accident, surgery) within 4 months prior to first meal administration
* Earlier participation in a study using iron stable isotopes or participation in any clinical study within the last 30 days
* Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood withdrawal)
* Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04194567
Study Brief:
Protocol Section:
NCT04194567