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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT05426395
Eligibility Criteria:
The inclusion criteria for pregnant women are as follows:
* Pregnant female
* Has an estimated gestational age of 25 to 28 weeks at study initiation
* Is between the ages of 18 and 45 years of age
* Lives in the study area and does not plan to travel outside of the study area for the duration of the trial
* Consents to participate in the trial
The exclusion criteria for pregnant women are as follows:
* Known multiple pregnancy (e.g. twins, triplets)
* Has severe anemia (hemoglobin \<7 g/dL)
* Has pre-pregnancy or early pregnancy Body Mass Index ≥ 35 kg/m2
* Has a self-reported pre-pregnancy history of type II diabetes mellitus, hypertension, or hypercholesterolemia.
* Has currently diagnosed preeclampsia or eclampsia.
* Has currently diagnosed gestational diabetes.
* Has currently diagnosed renal, liver, autoimmune, or bleeding disorders. The investigators will also assess all women for clinical signs of liver disease including: jaundice or yellowing of skin/sclera/mucosa, right upper quadrant tenderness or pain. All women will be given a liver function test, regardless of clinical signs of liver disease. The tests include: serum Alanine aminotransferase (ALT) and serum Aspartate aminotransferase (AST). Abnormal liver function is defined as the following in this study for women who the investigators screened during the 2nd trimester (25-26 weeks), ALT below 2 or above 33 U/L, or AST below 3 or above 33 U/L; for women screened during the 3rd trimester (27-28 weeks), ALT below 2 or above 25 U/L, or AST below 4 or above 32 U/L (25). Those with liver disease or abnormal liver function will be excluded from the study and referred for treatment.
* Has currently diagnosed congestive heart failure. The investigators will first look for clinical signs of heart failure, and the investigators will focus on the following: i) Fatigue with limitation in performance of normal activities; ii) Coughing, wheezing and breathing difficulty because of lung congestion; iii) Swelling of ankles, feet and legs; and iv) Shortness of breath especially when lying flat. The investigators will only perform lab testing for those who have clinical manifestation, and refer them to appropriate and timely care.
* Has a history of significant gastrointestinal surgeries, such as bariatric surgery, cholecystectomy, or other surgical procedures affecting the stomach, liver, bile ducts and/or small intestine that may disrupt enterohepatic recycling of vitamin B12.
* Has a condition requiring the use of the following medications: H2 blockers, proton pump inhibitors, or prokinetic agents.
* Reports regular use of an over-the-counter, high dose vitamin B12 supplementation. (This criteria does not refer to normal prenatal vitamin supplements which typically include approximately 1 RDA of vitamin B12 or 2.6 ug of vitamin B12. Women using multiple micronutrient supplements, or MMS, are eligible for the study).
* Reports cigarette smoking or tobacco chewing
* Reports heavy alcohol use (\>3 drinks per day, or \>7 drinks per week)
* Current malaria infection (per rapid diagnostic)
* HIV/AIDS infection (due to potential interaction between first-line antiretroviral dolutegravir and multivitamins that has been shown to decrease dolutegravir exposure by about 33%).
* Has a known allergy to corn or hydroxyethyl starch (HES).
The inclusion criteria for non-pregnant women are as follows:
* Is between the ages of 18 and 45 years of age.
* Lives in the study area and does not plan to travel outside of the study area for the duration of the trial
* Consents to participate in the trial
The exclusion criteria for non-pregnant women are as follows:
* Has severe anemia (hemoglobin \<8 g/dL)
* Has Body Mass Index ≥ 35 kg/m2
* Has a self-reported diagnosis of type II diabetes mellitus, hypertension, or hypercholesterolemia.
* Has currently diagnosed renal, liver, autoimmune, or bleeding disorders. The investigators will also assess all women for clinical signs of liver disease including: jaundice or yellowing of skin/sclera/mucosa, right upper quadrant tenderness or pain. Any woman with clinical signs of liver disease will be given a liver function test including: ALT, AST (26,27). Those with liver disease will be excluded from the study and referred for treatment.
* Has currently diagnosed congestive heart failure.
* Has a history of significant gastrointestinal surgeries, such as bariatric surgery, cholecystectomy, or other surgical procedures affecting the stomach, liver, bile ducts and/or small intestine that may disrupt enterohepatic recycling of vitamin B12.
* Has a condition requiring the use of the following medications: H2 blockers, proton pump inhibitors, or prokinetic agents.
* Reports regular use of an over-the-counter, high dose vitamin B12 supplementation.
* Reports cigarette smoking or tobacco chewing
* Reports heavy alcohol use (\>3 drinks per day, or \>7 drinks per week)
* Current malaria infection (per rapid diagnostic)
* HIV/AIDS infection (due to potential interaction between first-line antiretroviral dolutegravir and multivitamins that has been shown to decrease dolutegravir exposure by about 33%).
* Has a known allergy to corn or hydroxyethyl starch (HES).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05426395
Study Brief:
Protocol Section:
NCT05426395