Vitamin D and Pregnancy: Camden Study

Completed

• Conditions: Reproductive Effects; Pregnancy

• Registration Number: NCT02032459
• Lead Sponsor: Rowan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-09
• Study First Submitted: 2013-12-19
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1141

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal Vitamin D Status	Up to 5 years	Our primary objective is to determine the prognostic importance of maternal vitamin D status for birth weight, gestation duration and poor pregnancy outcomes (low birth weight, preterm delivery, and fetal growth restriction).

Secondary Outcome Measures

Name	Time	Method
Vitamin D Status in relations to pregnancy complications	Up to 5 years	To determine the relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).

Trial Locations

Locations (1)

Rowan University; 🇺🇸 Stratford, New Jersey, United States