CClinicalTrials.gg
CompletedNCT02032459Updated Jan 10, 2014

Vitamin D and Pregnancy: Camden Study

An observational study in Reproductive Effects and Pregnancy, sponsored by Rowan University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by Rowan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,141
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Reproductive Effects
  • Pregnancy

Keywords

  • Pregnancy
  • Minority Women
  • Preterm delivery
  • Fetal growth restriction
  • Preeclampsia
  • Gestational Diabetes
  • Vitamin D
03

In context

Lead sponsor

Rowan University is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study is conducted from previously 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).

Eligibility 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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,141 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Minority Women

    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).

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 5 years

Secondary outcomes

  1. 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).

    Time frame: Up to 5 years

Other outcomes

  1. 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.

    Time frame: Up to 5 years

07

Study locations

1 site
  • Rowan University
    Stratford, New Jersey 08084, United States
08

References and documents

Publications

  • 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. PubMed 23885046 ↗
  • 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. PubMed 22606373 ↗
  • 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. PubMed 19008055 ↗
  • Scholl TO, Chen X, Stein TP. Maternal calcium metabolic stress and fetal growth. Am J Clin Nutr. 2014 Apr;99(4):918-25. doi: 10.3945/ajcn.113.076034. Epub 2014 Feb 5. PubMed 24500145 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02032459
Lead sponsor
Rowan University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Theresa Scholl (Professor, Obstetrics and Gynecology, Rowan University) — Principal investigator
First posted
Jan 10, 2014
Start date
Apr 2007
Primary completion
Sep 2007
Last update
Jan 10, 2014

Study contacts

Theresa O Scholl, PhD, MPH
principal investigator · Rowan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion