Trial Outcomes & Findings for Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh (NCT NCT00198822)

Results Overview

Mortality evaluated on intent-to-treat basis

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

59666 participants

Primary outcome timeframe

Deaths during pregnancy through 12 weeks postpartum

Results posted on

2012-03-07

Participant Flow

Women were recruited into the trial from August 2001 to January 2007. As this was a community trial, we identified pregnant women by conducting a urine test on women reporting to be amenstrual from the last visit during 5 weekly visit cycles to their homes in rural communities of the districts of Rangpur and Gaibandha, Bangladesh.

Participant milestones

Participant milestones
Measure	1 Placebo Control Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
Overall Study STARTED	19876	19826	20019
Overall Study COMPLETED	19862	19806	19998
Overall Study NOT COMPLETED	14	20	21

Reasons for withdrawal

Reasons for withdrawal
Measure	1 Placebo Control Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
Overall Study Lost to Follow-up	14	20	21

Baseline Characteristics

Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Placebo Control n=19862 Participants Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement n=19806 Participants Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group n=19998 Participants Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy	Total n=59666 Participants Total of all reporting groups
Age Categorical <=18 years	5875 participants n=99 Participants	5774 participants n=107 Participants	5936 participants n=206 Participants	17585 participants n=7 Participants
Age Categorical Between 18 and 65 years	13973 participants n=99 Participants	14017 participants n=107 Participants	14056 participants n=206 Participants	42046 participants n=7 Participants
Age Categorical >=65 years	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants
Age Continuous	23.03 years STANDARD_DEVIATION 6.53 • n=99 Participants	23.17 years STANDARD_DEVIATION 6.56 • n=107 Participants	23.06 years STANDARD_DEVIATION 6.56 • n=206 Participants	23.09 years STANDARD_DEVIATION 6.55 • n=7 Participants
Sex: Female, Male Female	19862 Participants n=99 Participants	19806 Participants n=107 Participants	19998 Participants n=206 Participants	59666 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment Bangladesh	19862 participants n=99 Participants	19806 participants n=107 Participants	19998 participants n=206 Participants	59666 participants n=7 Participants

PRIMARY outcome

Timeframe: Deaths during pregnancy through 12 weeks postpartum

Population: As the study ended on the advice of the Data and Safety Monitoring Board, based on evidence of no difference, all enrolled women who had a chance of being followed through 84 days after the end of their pregnancy were included in the trial. The cohort included pregnancies identified between August 17, 2001 and January 5, 2006.

Mortality evaluated on intent-to-treat basis

Outcome measures

Outcome measures
Measure	1 Placebo Control n=19862 Participants Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement n=19806 Participants Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group n=19998 Participants Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
All-cause, Pregnancy-related Mortality	41 Participants	47 Participants	50 Participants

SECONDARY outcome

Timeframe: Deaths through the 1st 12 weeks of life

Population: Mortality evaluated on intent-to-treat basis

Outcome measures

Outcome measures
Measure	1 Placebo Control n=13965 Participants Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement n=13898 Participants Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group n=14018 Participants Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
All-cause 3-month Infant Mortality	951 participants	904 participants	979 participants

SECONDARY outcome

Timeframe: through the 1st 24 weeks following termination of pregnancy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 24 weeks after birth

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through the 1st 12 weeks after birth

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 24 weeks after birth

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Third trimester of pregnancy (about the 32nd week of gesatation)

Outcome measures

Outcome measures
Measure	1 Placebo Control n=332 Participants Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement n=367 Participants Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group n=368 Participants Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)	0.11 Plasma beta-carotene micromoles / liter Standard Deviation 0.09	0.12 Plasma beta-carotene micromoles / liter Standard Deviation 0.12	0.12 Plasma beta-carotene micromoles / liter Standard Deviation 0.10

SECONDARY outcome

Timeframe: Third trimester of pregnancy (about the 32nd week of gestation)

Outcome measures

Outcome measures
Measure	1 Placebo Control n=332 Participants Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy	2 Vitamin A Supplement n=367 Participants Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy	3 Beta-Carotene Group n=368 Participants Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)	1.02 micromoles per liter Standard Deviation 0.31	1.25 micromoles per liter Standard Deviation 0.33	1.06 micromoles per liter Standard Deviation 0.33

Adverse Events

1 Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Vitamin A Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3 Beta-Carotene Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Keith P West, Jr., Principal Investigator

Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health

Phone: 410-955-2061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place