Vitamin D and Pregnancy: Camden Study

Rowan University

Status: Completed

Conditions: Reproductive Effects; Pregnancy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02032459

5R21HD058128 (U.S. NIH Grant/Contract)

0320070046

Details and patient eligibility

About

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.

Enrollment: 1,141 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,141 participants in 1 patient group

Minority Women

Description:

Study data pulled from already 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).