Trial record 7 of 9 for:    nichd Preeclampsia/Eclampsia

Vitamin D and Pregnancy: Camden Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Theresa Scholl, Rowan University
ClinicalTrials.gov Identifier:
NCT02032459
First received: December 19, 2013
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.

Condition
Reproductive Effects
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D Status in Pregnant Women

Resource links provided by NLM:


Further study details as provided by Rowan University:

Primary Outcome Measures:
  • Maternal Vitamin D Status [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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:
  • Vitamin D Status in relations to pregnancy complications [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    To determine the relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).


Other Outcome Measures:
  • Relationship of Vitamin D to maternal diet, etc. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood and urine collection: Fasting (>8 h) maternal blood samples were collected at entry to care and week 28 of gestation. Blood specimens were also collected at 1-hour of the 50g glucose challenge test. Fasting blood samples collected at each visit were immediately refrigerated and centrifuged at 4oC. Plasma and serum were preserved from each patient (at -70oC) until assayed. 20 ml of urine was collected at entry to care and week 28 in metal free plastic containers and stored at -70oC.


Enrollment: 1141
Study Start Date: April 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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).

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032459

Locations
United States, New Jersey
Rowan University
Stratford, New Jersey, United States, 08084
Sponsors and Collaborators
Rowan University
Investigators
Principal Investigator: Theresa O Scholl, PhD, MPH Rowan University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theresa Scholl, Professor, Obstetrics and Gynecology, Rowan University
ClinicalTrials.gov Identifier: NCT02032459     History of Changes
Other Study ID Numbers: 0320070046, 5R21HD058128
Study First Received: December 19, 2013
Last Updated: January 8, 2014
Health Authority: DHHS FWA Assurance Identifier: FWA00004917

Keywords provided by Rowan University:
Pregnancy
Minority Women
Preterm delivery
Fetal growth restriction
Preeclampsia
Gestational Diabetes
Vitamin D

Additional relevant MeSH terms:
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014