Skip to main content
OpenTrials
Completed

NCT Number: NCT02032459

Vitamin D and Pregnancy: Camden Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Maternal Vitamin D Status

    Time frame: 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 outcomes

  1. Vitamin D Status in relations to pregnancy complications

    Time frame: Up to 5 years

    To determine the relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).

Other outcomes

  1. Relationship of Vitamin D to maternal diet, etc.

    Time frame: Up to 5 years

    To describe the relationship of maternal vitamin D status to maternal diet and supplement use, season of year, ethnicity, overweight/obesity, and other maternal characteristics.

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Vitamin D Status in Pregnant Women

Important dates

Study start
2007
Primary completion
2007
First posted
Jan 10, 2014
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.