Phase 3
N=59,721
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Vitamin A Deficiency · Maternal Mortality · Infant Mortality
Bottom Line
View on ClinicalTrials.gov: NCT00198822 ↗Enrolled (actual)
59,721
Serious AEs
—
Results posted
Oct 2011
Primary outcome: Primary: All-cause, Pregnancy-related Mortality — 41; 47; 50 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin A or Beta-Carotene Supplements (Dietary_supplement)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause, Pregnancy-related Mortality |
41; 47; 50 | 0.05 |
| SECONDARY All-cause 3-month Infant Mortality |
951; 904; 979 | — |
| SECONDARY Maternal Morbidity, Including Obstetric Complications |
— | — |
| SECONDARY Gestational Age at Birth |
— | — |
| SECONDARY Fetal Growth and Postnatal Infant Growth Through Three Months of Age |
— | — |
| SECONDARY Infant Morbidity Through 3 Months of Age |
— | — |
| SECONDARY Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother) |
0.11; 0.12; 0.12 | — |
| SECONDARY Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother) |
1.02; 1.25; 1.06 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Married women of reproductive age
- First pregnancy during time period of trial
Exclusion Criteria
- Premenarchial girls
- Married women with a previous pregnancy enrolled into the trial
- Previously married women who have moved into the study area
- Single women (never married, widowers)
- Women who are sterilized (or whose husbands are sterilized)
- Menopausal women
Data sourced from ClinicalTrials.gov (NCT00198822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.