Please select the eligibility criteria that correspond to the clinical trial below.
Title: Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
Brief Summary: There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.


Options:
A: Inclusion Criteria:

* Women aged 18 to \<35 years.
* Current residence in Dhaka at a fixed address
* Plans to have the delivery performed at the Shimantik maternity center, and to stay in Dhaka throughout the pregnancy and for at least one month past the date of delivery.
* Gestational age of 26th to 29th (inclusive), estimated based on the first day of the last menstrual period (LMP).

Exclusion Criteria:

* Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month prior to enrolment, or refusal to stop taking supplemental vitamin D at any dose after enrollment.
* Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
* Severe anemia (hemoglobin concentration \< 70 g/L).
* Complicated medical or obstetric history that may increase the risk of preterm birth or labor/delivery complications, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, preterm labor, or multiple gestation).
* Prior history of delivery of an infant with a major congenital anomaly, birth asphyxia, or perinatal death (stillbirth or death within first week of life).
B: Inclusion Criteria:

* Women between 18-42 years of age
* within 18 plus/minus 3 weeks gestation
* planning to breastfeed their infant
* a singleton pregnancy

Exclusion Criteria:

* Any co-morbid condition such pre-gestational diabetes, TB, cardiac or renal disease, HIV/AIDS, chronic hypertension, inflammatory bowel disease, autoimmune disease, liver disease, or epilepsy; conditions associated with vitamin D malabsorption: celiac disease, gastric bypass;
* History of previous adverse pregnancy outcome \[preterm delivery \<37; weeks GA, stillbirth, severe pre-eclampsia, eclampsia, HELLP syndrome (hemolytic anemia, elevated liver enzymes, and low platelet count)\];
* Women will also be ineligible if they are taking more than 10 µg day supplemental vitamin D or drugs known to interfere with vitamin D metabolism (i.e corticosteroids).
C: Inclusion criteria

* Currently lactating mothers at least 18 years of age
* Willing to continue exclusively breastfeeding their infant throughout the study interval
* The infant is 1-6 months of age at the beginning of the study
* Willing and able to participate in all aspects of the study
* Mother and infant are in good health, as determined by the study investigator
* Have been provided with, understand, and have signed the informed consent for themselves and their child.

Exclusion criteria

* Have recently travelled (within the preceding 30 days) or plan to travel south of 35 degrees north latitude during the study interval
* Have recently or plan to engage in indoor tanning
* Are currently taking medications that affect vitamin D metabolism, like steroids, anticonvulsants, or barbiturates
* Are nursing multiple infants (e.g. twins)
* Are taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements
* Are taking greater than the standard daily dose of 400 IU of vitamin D found in prenatal vitamins
* Infant weight below 1.67 kg
* Mothers with baseline 25(OH)D levels \>70 ng/ml, and/or infants with baseline 25(OH)D levels \>70 ng/ml
* History of kidney stones
D: Inclusion Criteria:

* Infants born to women enrolled in the MDIG trial (NCT01924013).
* Maternal inclusion criteria (at time of enrolment) will be:
* At least 18 years of age
* 17 to 24 completed weeks of gestation
* Intends to permanently reside in the trial catchment area for at least 18 months
* Family plans to reside in catchment area for the first 6 months postnatal
* Provides written informed consent for participation

Exclusion Criteria:

* Mother withdrawn from MDIG trial prior to delivery
* Failure to provide consent for participation in sub-study

Answer: D