Vitamin D and Pregnancy: Camden Study

Vitamin D Status in Pregnant Women

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02032459

Enrollment

1141

Registered

2014-01-10

Start date

2007-04-30

Completion date

Unknown

Last updated

2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Reproductive Effects

Keywords

Pregnancy, Minority Women, Preterm delivery, Fetal growth restriction, Preeclampsia, Gestational Diabetes, Vitamin D

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Other

Measure	Time frame	Description
Relationship of Vitamin D to maternal diet, etc.	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.

Countries

United States

Outcome results