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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT06046703
Eligibility Criteria:
Inclusion Criteria:
* Before 27 weeks of pregnancy
* Age \>18 years
* Strict plant-based diet (vegan diet), defined as a diet without ingestion of animal products (i.e., intake less than once a month during) the entire pregnancy or omnivorous diet, defined as a diet that includes meat
* Willing and able to give written informed consent and to understand, participate and comply with the research project requirements
Exclusion Criteria:
* Food allergy that influences the nutritional intake, e.g., milk allergy, celiac disease, and lactose intolerance
* Medical history of gastrointestinal diseases such as Crohn's disease and other diseases associated with vitamin B12 deficiencies such as (pre-existing) diabetes.
* Medical history of abdominal surgery interfering with nutrient uptake, such as gastric bypass and intestinal resections
* Pre-existing cardio-vascular diseases or auto-immune diseases
* Insufficient understanding of the Dutch language
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06046703
Study Brief:
Protocol Section:
NCT06046703