Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198822
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2005-09-12
Brief Title:
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Status:
COMPLETED
Status Verified Date:
2012-03
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 trial is to determine whether providing women with a weekly oral supplement of vitamin A either preformed or as beta-carotene at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum can reduce the risk of maternal mortality fetal loss or infant mortality
Detailed Description:
Maternal mortality and vitamin A deficiency coexist in rural South Asia In Nepal weekly supplementation with vitamin A or beta-carotene during the child-bearing years reduced all-cause maternal mortality and in night blind women also infant mortality The present trial is testing the efficacy of the same supplements from 9 weeks gestation to 12 weeks postpartum The planned sample size is 68000 pregnancies It is being conducted in 19 rural unions covering an area of 750 sq km with a population of 580000 in Gaibandha and Southern Rangpur Districts in Northern Bangladesh The study area was mapped as 596 sectors unit of randomization each comprising 200-275 households 135000 houses were numerically addressed and at the outset 103000 women were listed Women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing Newly married women are prospectively enlisted for pregnancy surveillance Following informed consent urine-positive pregnant women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin A 42 mg of beta-carotene or placebo Vital events are recorded weekly through 3 months postpartum Trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester At 3 months postpartum interviewers assess both mother and infant for health and nutritional status including apparent birth defects that are later physician-confirmed An additional home health assessment occurs at 6 months post partum and vital status is recorded for mother and infant at one year postpartum A 3 subsample of enrolled pregnant women participate in a substudy involving enhanced clinical anthropometric biochemical body compositional morbidity and interview-based assessment protocols in the 1st 2nd and 3rd trimesters and at 3 months post-partum Reported maternal and infant deaths are verified and causes ascertained during verbal autopsy interviews with family members of the deceased
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