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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT05934318
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women aged 16-40 years,
* inclusive to 24 weeks gestational age as confirmed by ultrasound,
* who have a viable singleton pregnancy,
* are residents of the study area,
* willing to adhere to scheduled and unscheduled study visit procedures,
* willing to deliver in a study clinic or hospital
Exclusion Criteria:
* multiple pregnancies (i.e. twin/triplets);
* pre-existing hypertension, renal disease and/or diabetes, or severe anaemia (Hb \< 5 g/dL);
* HIV-positive or HIV status unknown;
* malformations or nonviable pregnancy observed on enrolment ultrasound;
* known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet;
* unable to give consent; or concurrent participation in any other clinical trial
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT05934318
Study Brief:
Protocol Section:
NCT05934318