Please select the eligibility criteria that correspond to the clinical trial below.
Title: Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum
Brief Summary: Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.


Options:
A: 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* Mother withdrawn from MDIG trial prior to delivery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
B: 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
C: Inclusion Criteria:

* Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem

Exclusion Criteria:

* Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
* Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
D: Inclusion Criteria:

* Mother plans to breastfeed exclusively for at least six months
* Mother is in good health
* Infant is 35 weeks' gestation or greater
* Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).

Exclusion Criteria:

* Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months
* Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
* Infant is less than 35 weeks' gestation
* Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
* Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
* Mother has history of hypercalciuria

Answer: B