Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Brief Summary: The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.


Options:
A: Inclusion Criteria:

* Pregnant and consenting to study participation and HIV testing (if not already performed)
* mid-upper-arm circumference (MUAC) ≤ 23 cm
* planning to stay in the area and attend the clinic during pregnancy and for 3 months post partum

Exclusion Criteria:

* Pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
* Severe anemia (Hg \<7.0 mg/dl)
* Severe malnutrition
* under 18 years of age
* over estimated 35 weeks of gestation
B: Inclusion Criteria:

* at least 18 years of age
* in first trimester of pregnancy
* plans to reside in the same village during the entire pregnancy

Exclusion Criteria:

* a minor
* not in first trimester of pregnancy
* plans to relocate during the pregnancy
C: Inclusion Criteria:

* 18-45 years
* Not taking a folic acid containing supplement

Exclusion Criteria:

* Adults who have medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, or psychiatric illness
* Adults who are taking medications known to interfere with folate metabolism (i.e. phenytoin, sulphasalazine, methotrexate)
* Adults with wheat, milk allergy or lactose intolerance
* Adults with known B12 deficiency
* Adults who consume more than 1 alcoholic drink/day on average (1 drink=12 oz beer, 5 oz wine or 1.5 oz spirits)
* Women have been pregnant during the year previous
* Women planning a pregnancy in the next year
* Women who believe they may become pregnant during the study
* Women who have had a known previous neural tube defect affected pregnancy
* Adults who are unable to provide informed consent
D: Inclusion Criteria:

1. One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
2. An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
3. Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
4. Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
5. Age between 21 and 80 years at the time of the intake colonoscopy.
6. For women of childbearing potential, agreement to use effective birth control for the duration of the study.
7. Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
8. Not randomized previously or currently in a chemoprevention trial, except for the: "Nutritional Prevention of Large Bowel Polyps" Study (Polyps Prevention Study I); and brief participation in the "VA Cooperative Study" with no continuing involvement.

Exclusion Criteria:

1. Invasive carcinoma in any colonic polyp removed.
2. Familial colonic polyposis syndromes.
3. Ulcerative colitis or Crohn's disease.
4. Malabsorption syndrome (e.g. pancreatic insufficiency).
5. Large bowel resection for any reason.
6. Diagnosed narcotic or alcohol dependence
7. Contraindication to aspirin use, including:

   1. documented peptic ulcer disease in the past 20 years
   2. aspirin sensitivity
   3. bleeding diathesis, including hemorrhagic stroke
8. Likelihood of NSAID use

   1. recurring arthritis or other musculo-skeletal problems
   2. frequent NSAID use in 5 years preceding
   3. history of stroke or TIAs
   4. history of angina or myocardial infarction
   5. desire to take aspirin for the prevention of cardiovascular disease
9. Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
10. Pregnancy or lactation.

Answer: B