Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292591
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2006-02-15
Brief Title:
Evaluation of Vitamin D Requirements During Pregnancy
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Evaluation of Vitamin D Requirements During Pregnancy
Status:
COMPLETED
Status Verified Date:
2016-08
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:
The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester Mothers will be randomized to one of three vitamin D dosing groups 400 2000 or 4000 international units per day It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race
Detailed Description:
The prevalence of hypovitaminosis D in reproductive aged African-American women occurs at a rate of 40 Two factors have contributed to this public health problem an inadequate DRI for vitamin D and avoidance of sun exposureuse of sunscreen This startling rate of hypovitaminosis D requires that the DRI for vitamin D in pregnancy be evaluated in a detailed manner The Cochrane Library 2002 released a report stating that there is insufficient data to evaluate the effects of vitamin D supplementation during pregnancy Recently the safety of prolonged supplementation with up to 25xs DRI 10000 IUday was demonstrated in nonpregnant adults It is essential to determine what dose of vitamin D is required to eliminate hypovitaminosis D during pregnancy and provide the fetusneonate with adequate vitamin D stores during development and growth particularly in darkly pigmented individuals The aim of this research proposal then is to determine the efficacy effectiveness and safety of maternal vitamin D supplementation as a function of ethnicity and UV exposure in the prevention of hypovitaminosis D in the pregnant mother and her fetusneonate We hypothesize that darkly pigmented mothers will require substantially higher oral supplementation with vitamin D to eliminate hypovitaminosis D as compared to their Caucasian counterparts We propose a comprehensive clinical trial to test our hypothesis Mothers at 12 weeks gestation will be randomized to one of three vitamin D treatment groups
1 Control 400-
2 2000- or
3 4000 IUday to be continued throughout pregnancy
Calcium and vitamin D homeostasis and skeletal remodeling in the mother will be monitored closely throughout the pregnancy Bone density of the mother will be measured at 12 weeks gestation and one-month postpartum Follow-up growth and skeletal integrity assessments of the infant will be performed at birth 1 6 and 12 months stratified by infant feeding regime Through these proposed studies the prevalence of hypovitaminosis D among mothers their developing fetuses and neonates and the utility of maternal therapeutic intervention with vitamin D for both mother and fetusinfant will be assessed
1 Control 400-
2 2000- or
3 4000 IUday to be continued throughout pregnancy
Calcium and vitamin D homeostasis and skeletal remodeling in the mother will be monitored closely throughout the pregnancy Bone density of the mother will be measured at 12 weeks gestation and one-month postpartum Follow-up growth and skeletal integrity assessments of the infant will be performed at birth 1 6 and 12 months stratified by infant feeding regime Through these proposed studies the prevalence of hypovitaminosis D among mothers their developing fetuses and neonates and the utility of maternal therapeutic intervention with vitamin D for both mother and fetusinfant will be assessed
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HD043921 | NIH | None | httpsreporternihgovquickSearch5R01HD043921 |