Clinical trial NCT02032459: Vitamin D and Pregnancy: Camden Study
Official title: Vitamin D Status in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Effects
Pregnancy
Keywords: Pregnancy
Minority Women
Preterm delivery
Fetal growth restriction
Preeclampsia
Gestational Diabetes
Vitamin D
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-01-10
Enrollment: 1141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is conducted from previously collected data (N=1141) from the Camden Study of low income gravidae and minority gravidae (White, African-American and Hispanic) living in the northeastern United States (New Jersey).

Brief summary: Vitamin D is present in food either naturally or by fortification and included in nutritional supplements. It is also synthesized photochemically by the skin from ultraviolet B radiation. Vitamin D synthesis varies by season and with latitude as well as according to intensity of skin pigmentation. Recent research in the United States found lower circulating levels of 25 (OH) D, the primary indicator of vitamin D status, among minority women who were either pregnant or in their reproductive years. The extent to which maternal vitamin D has an influence on the course and outcome of human pregnancy remains to be more completely studied. We propose to use the HPLC method to assay cholecaliferol (vitamin D3) and ergocalciferol (vitamin D2) to assess maternal vitamin D status. This will be accomplished by analyzing existing fasting samples and data derived from the 2001-2006 cohort (N=1141) of young, low income minority gravidae from Camden, New Jersey to determine:

1. The prognostic importance of maternal vitamin D status for birth weight, gestation duration and poor pregnancy outcomes (low birth weight, preterm delivery, fetal growth restriction).
2. The relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).
3. The relationship of maternal vitamin D status to maternal diet and supplement use, season of year, ethnicity, overweight/obesity, and other maternal characteristics.


Eligibility criteria: Inclusion Criteria: Positive pregnancy test, informed consent, gestation at entry ≤20 weeks

Exclusion Criteria: Women with serious non-obstetric problems including lupus, type 1 or type 2 diabetes, seizure disorders, malignancies, acute or chronic liver or renal diseases, drug or alcohol abuse and psychiatric problems were not eligible for participation.

Primary outcomes:
measure: Maternal Vitamin D Status
timeFrame: Up to 5 years
Secondary outcomes:
measure: Vitamin D Status in relations to pregnancy complications
timeFrame: Up to 5 years
Other outcomes:
measure: Relationship of Vitamin D to maternal diet, etc.
timeFrame: Up to 5 years
Locations:
city: Stratford
country: United States
facility: Rowan University
state: New Jersey
Study officials:
affiliation: Rowan University
name: Theresa O Scholl, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scholl TO, Chen X, Stein TP. Vitamin D, secondary hyperparathyroidism, and preeclampsia. Am J Clin Nutr. 2013 Sep;98(3):787-93. doi: 10.3945/ajcn.112.055871. Epub 2013 Jul 24.
citation: Scholl TO, Chen X, Stein P. Maternal vitamin D status and delivery by cesarean. Nutrients. 2012 Apr;4(4):319-30. doi: 10.3390/nu4040319. Epub 2012 Apr 20.
citation: Scholl TO, Chen X. Vitamin D intake during pregnancy: association with maternal characteristics and infant birth weight. Early Hum Dev. 2009 Apr;85(4):231-4. doi: 10.1016/j.earlhumdev.2008.10.006. Epub 2008 Nov 12.
citation: Scholl TO, Chen X, Stein TP. Maternal calcium metabolic stress and fetal growth. Am J Clin Nutr. 2014 Apr;99(4):918-25. doi: 10.3945/ajcn.113.076034. Epub 2014 Feb 5.