Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
Brief Summary: Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.


Options:
A: Inclusion Criteria:

Mother:

* Pregnant in week 22-26 of gestation
* Participating in the ABC-cohort
* Living in Sealand, Denmark
* Fluent in Danish
* Willing to let the child participate in the study

Exclusion Criteria:

Mother:

* Intake of more than 400 IU of vitamin D during the last 6 months
* Endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or Diabetes type 1
* Tuberculosis
* Sarcoidosis
* In need of diuretics or heart medication including calcium channel blockers
B: Inclusion Criteria:

* Pregnant women gestational age (GA)\< 14 weeks at screening visit. Middle Eastern woman (Middle East countries defined by WHO: Bahrain, Egypt, Iran, Iraq, Palestine, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, , United Arab Emirates, Yemen)
* 25(OH)D level between 10ng/ml and 30ng/ml
* Age \> 18 years
* Vitamin D supplementation ≤ 200 IU daily (If daily vitamin D supplementation \> 200 IU daily, at enrollment, the pregnant women will be advised to adjust prenatal multivitamin doses in such a way that total vitamin D supplementation per week doesn't exceed 1400 IU per week, in consultation with primary Obstetric and Gynecology (OB-GYN) physician.)

Exclusion Criteria:

* 25(OH)D level \< 10 ng/ml or \> 30 ng/ml.
* Known metabolic bone disease
* Current medications likely to interfere with vitamin D metabolism (enzyme inducing anticonvulsants, anti -TB)
* Vitamin D supplementation \> 600 IU daily
* Pregnant women with twins
C: Inclusion Criteria:

* Pregnant women
* Less than 20 weeks gestation
* Over 18 years of age
* Able to swallow nutritional supplements

Exclusion Criteria:

* Use of medications known to affect vitamin D metabolism
* Diagnosis of type 1 diabetes
* History of thyroid, renal, or liver disease
* Problems with digestion or absorption
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: C