Vitamin D and Pregnancy: Camden Study

Pregnancy Clinical Trial

Official title:

Vitamin D Status in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032459
• Other study ID #: 0320070046
• Secondary ID: 5R21HD058128
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: January 8, 2014
• Start date: April 2007

Study information

• Verified date: January 2014
• Source: Rowan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: DHHS FWA Assurance Identifier: FWA00004917
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1141
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy
• Reproductive Effects

Locations

Country	Name	City	State
United States	Rowan University	Stratford	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rowan University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship of Vitamin D to maternal diet, etc.	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.	Up to 5 years	No
Primary	Maternal Vitamin D Status	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).	Up to 5 years	No
Secondary	Vitamin D Status in relations to pregnancy complications	To determine the relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).	Up to 5 years	No