Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412074
Status:
COMPLETED
Last Update Posted:
2018-06-04
First Post:
2006-12-13
Brief Title:
Establishing the Vitamin D Requirements During Lactation
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Establishing the Vitamin D Requirements During Lactation
Status:
COMPLETED
Status Verified Date:
2018-05
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 and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant
Detailed Description:
Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3 Mothers lactating or nonlactating controls will be randomized to either Group A standard treatment400 IU D3d Group B 2400 IU D3d or Group C 6400 IU D3d Infants of mothers randomized to Group A will receive 400 IU D3d recommended practice and infants of mothers assigned to Groups B or C will receive placebo On 252009 the protocol was amended and the Group B arm was dropped infants of active subjects randomized to Group B as of 252009 were put on open label treatment 400 IU D3d through study completion Newly enrolled subjects after this date were randomized to Group A or Group C only
By measuring an array of indicatorscalcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored Through this study the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed
By measuring an array of indicatorscalcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored Through this study the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 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 |
|---|---|---|---|
| R01HD047511 | NIH | None | httpsreporternihgovquickSearchR01HD047511 |