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

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Canadian International Development Agency
The Sight and Life Research Institute
Access Business Group
Information provided by (Responsible Party):
Keith P. West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00198822
First received: September 12, 2005
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
Results First Received: September 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Vitamin A Deficiency
Maternal Mortality
Infant Mortality
Intervention: Dietary Supplement: Vitamin A or Beta-Carotene Supplements

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    1 Placebo Control     2 Vitamin A Supplement     3 Beta-Carotene Group  
STARTED     19876 [1]   19826 [2]   20019 [3]
COMPLETED     19862 [4]   19806 [5]   19998 [6]
NOT COMPLETED     14     20     21  
Lost to Follow-up                 14                 20                 21  
[1] No. of consenting pregnant women in the placebo arm of trial cohort
[2] No. of consenting pregnant women in the vitamin A arm of trial cohort
[3] No. of consenting pregnant women in the beta-catorene arm of trial cohort
[4] No. of consented pregnant women in placebo arm with vital status known at 12 weeks postpartum
[5] No. of consented pregnant women in vitamin A arm with vital status known at 12 weeks postpartum
[6] No. of consented pregnant women in beta-catorene arm with vital status known at 12 weeks postpartum



  Baseline Characteristics
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    1 Placebo Control     2 Vitamin A Supplement     3 Beta-Carotene Group     Total  
Number of Participants  
[units: participants]
 		  19862     19806     19998     59666  
Age [1]
[units: participants]
 		       
<=18 years     5875     5774     5936     17585  
Between 18 and 65 years     13973     14017     14056     42046  
>=65 years     0     0     0     0  
Age [1]
[units: years]
Mean ± Standard Deviation 		  23.03  ± 6.53     23.17  ± 6.56     23.06  ± 6.56     23.09  ± 6.55  
Gender  
[units: participants]
 		       
Female     19862     19806     19998     59666  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
Bangladesh     19862     19806     19998     59666  
[1] A very small number of women in the study were unable to recollect or even work out their age. In rural South Asia, this is not uncommon and of the 35 women for whom we do not have an age, 14 are in the placebo group, 15 in the Vitamin A group and 6 in the beta-carotene group.



  Outcome Measures
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1.  Primary:   All-cause, Pregnancy-related Mortality   [ Time Frame: Deaths during pregnancy through 12 weeks postpartum ]
  Show Outcome Measure 1

2.  Secondary:   All-cause 3-month Infant Mortality   [ Time Frame: Deaths through the 1st 12 weeks of life ]
  Show Outcome Measure 2

3.  Secondary:   Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)   [ Time Frame: Third trimester of pregnancy (about the 32nd week of gesatation) ]
  Show Outcome Measure 3

4.  Secondary:   Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)   [ Time Frame: Third trimester of pregnancy (about the 32nd week of gestation) ]
  Show Outcome Measure 4

5.  Secondary:   Maternal Morbidity, Including Obstetric Complications   [ Time Frame: through the 1st 24 weeks following termination of pregnancy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Gestational Age at Birth   [ Time Frame: within 24 weeks after birth ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Fetal Growth and Postnatal Infant Growth Through Three Months of Age   [ Time Frame: through the 1st 12 weeks after birth ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Infant Morbidity Through 3 Months of Age   [ Time Frame: within 24 weeks after birth ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Prof. Keith P West, Jr., Principal Investigator
Organization: Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health
phone: 410-955-2061
e-mail: kwest@jhsph.edu


Publications of Results:

Other Publications:

Publications automatically indexed to this study:


Responsible Party: Keith P. West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00198822     History of Changes
Other Study ID Numbers: GHS-A-00-03-00019-00
Study First Received: September 12, 2005
Results First Received: September 1, 2011
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board
Bangladesh: Bangladesh Medical Research Council