Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-20 @ 1:40 PM
Study NCT ID:
NCT02032459
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2013-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Pregnancy: Camden Study
Sponsor:
Rowan University
Organization:
Study Overview
Official Title:
Vitamin D Status in Pregnant Women
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R21HD058128 | NIH | None | https://reporter.nih.gov/quic… | View |