Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh.
Brief Summary: The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3 supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1 year of age among infants born to women who received vitamin D 28,000 U/week during pregnancy. Infants enrolled in the study will be followed for 2 years to document the persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300 pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months postpartum. In addition to linear length, the trial will include analyses of inflammatory and hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D metabolism, and diarrheal and respiratory morbidity in the infants.


Options:
A: Inclusion Criteria:

* Healthy women, age 18 to \< 35 years, who are clients at the Shimantik clinic or friends/relatives of Shimantik clients.
* Current permanent residence in Dhaka at a fixed address, and have plans to stay in Dhaka for at least 4 months.
* Pregnant women: Enrolled between 26th and 30th week of gestation (participants enrolled in 26th week will not start on-study until the 27th week or later), with a normal medical and obstetric history. Gestational age will be estimated based on the first day of the last menstrual period (LMP).
* Informed consent provided after having an opportunity to consult with husband and/or family members.

Exclusion Criteria:

* Current self-reported use of any non-food-based dietary supplements containing vitamin D (i.e., commercial micronutrient pills or capsules containing vitamin D).
* Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
* Severe anemia (hemoglobin concentration \< 70 g/L).
* Hypertension (systolic blood pressure \>= 140 mmHg or diastolic blood pressure \>= 90 mmHg on at least two measurements).
* In pregnant women: previous history of giving birth to an infant with congenital anomalies.
* In non-pregnant women: currently breast-feeding.
B: Inclusion Criteria:

* Women aged ≥18 years old
* HIV-positive
* Receiving HAART
* Pregnant and of 12-27 weeks gestation (Second Trimester)
* Calcium levels in the normal physiologic range (≤2.6 mmol/L)

Exclusion Criteria:

* Enrolled in any other clinical trial
C: Inclusion Criteria:

* Women aged 18 years and above.
* Gestational age of 17 to 24 completed weeks estimated based on recalled last menstrual period (LMP) and/or ultrasound.
* Intends to permanently reside in the trial catchment area for at least 18 months.

Exclusion Criteria:

* History of medical conditions that may predispose the participant to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, or history of renal calculi.
* High-risk pregnancy based on one or more of the following findings by point-of-care testing:

  * Severe anemia: hemoglobin \<70 g/L assessed by Hemocue
  * Moderate-severe proteinuria: ≥ 300 mg/dl (3+ or 4+) based on urine dipstick
  * Hypertension: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg
* Multiple gestation, major congenital anomaly, or severe oligohydramnios based on maternal history and/or ultrasound.
* Unwillingness to stop taking non-study vitamin D or calcium supplements or a multivitamin with calcium and/or vitamin D.
* Currently prescribed vitamin D supplements as part of a physician's treatment plan for vitamin D deficiency.
* Previous participation in the same study.
D: Inclusion Criteria:

* 13-19 y old
* between 23 and 29 wk of gestation
* primiparous
* carrying single fetus
* intending to exclusively or predominantly breastfeed

Exclusion Criteria:

* chronic health problems
* smokers
* users of nutritional supplements, except iron supplements provided during standard prenatal care

Answer: C