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Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)

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ClinicalTrials.gov Identifier: NCT00860470
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Mahidol University
Johns Hopkins University
Beximco
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Keith P. West, Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Infant Mortality
Preterm Birth
Low Birth Weight
Neonatal Mortality
Perinatal Mortality
Interventions Dietary Supplement: Iron (27 mg) - folic acid (600 ug)
Dietary Supplement: Multiple micronutrient
Enrollment 44567
Recruitment Details Enumeration of women began in December 2007, and active recruitment of pregnant women into the trail began in January 2008. Women were enrolled into the trial by community workers from the projects who visited them at home.
Pre-assignment Details  
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Period Title: Overall Study
Started 22162 22405
Completed 22114 22346
Not Completed 48 59
Reason Not Completed
Death             6             10
Moved away             8             10
Lost to Follow-up             34             39
Arm/Group Title Iron and Folate Multiple Micronutrient Total
Hide Arm/Group Description

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Total of all reporting groups
Overall Number of Baseline Participants 22162 22405 44567
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22162 participants 22405 participants 44567 participants
24.3  (6.43) 24.4  (6.44) 24.3  (6.43)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22162 participants 22405 participants 44567 participants
Female 22,162 22,405 44567
Male 0 0 0
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian, Bangladeshi Number Analyzed 22162 participants 22405 participants 44567 participants
22,162 22,405 44567
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bangladesh Number Analyzed 22162 participants 22405 participants 44567 participants
22,162 22,405 44567
Gestational Age in weeks  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 22162 participants 22405 participants 44567 participants
10.34  (4.7) 10.28  (4.7) 10.30  (4.7)
Literacy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22162 participants 22405 participants 44567 participants
Literate 12,816 12,985 25801
Illiterate 9,346 9,420 18766
Parity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22162 participants 22405 participants 44567 participants
0 6,671 6,647 13318
1-3 13,255 13,520 26775
>=4 2,186 2,194 4380
Previous Pregnancy Loss  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22162 participants 22405 participants 44567 participants
4,974 5,106 10080
1.Primary Outcome
Title Infant Mortality Through 6 mo of Age
Hide Description Risk of Infant Mortality to Age 6 months (180 days)
Time Frame Dec 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 14142 14374
Measure Type: Number
Unit of Measure: participants
764 741
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Regression, Logistic
Comments Bonferroni-adjusted alpha=0.01 (for 5 comparisons)
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.86 to 1.06
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
2.Secondary Outcome
Title Neonatal Mortality
Hide Description Risk of neonatal Mortality (28 days of life)
Time Frame Dec 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 14142 14374
Measure Type: Number
Unit of Measure: participants
625 626
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.88 to 1.20
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
3.Secondary Outcome
Title Post-neonatal Mortality
Hide Description Risk of Post-neonatal Mortality (29th -180th day of life)
Time Frame Dec 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 13517 13748
Measure Type: Number
Unit of Measure: participants
139 115
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.63 to 1.04
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
4.Secondary Outcome
Title Still Birth Rates
Hide Description Risk of Still birth
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 14858 15022
Measure Type: Number
Unit of Measure: participants
716 648
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Logistic
Comments Bonferroni-adjusted alpha=0.01 (for 5 comparisons)
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.81 to 0.99
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
5.Secondary Outcome
Title Preterm Birth
Hide Description Risk of being born before 37 weeks of gestation
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 13333 13475
Measure Type: Number
Unit of Measure: participants
2912 2510
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Bonferroni-adjusted alpha=0.01 (for 5 comparisons)
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.80 to 0.91
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
6.Secondary Outcome
Title Extremely Pre-term
Hide Description Risk of birth before 28 weeks gestation
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 13333 13475
Measure Type: Number
Unit of Measure: participants
136 106
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.57 to 0.97
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
7.Secondary Outcome
Title Very Pre-term
Hide Description Risk of birth between 28 and 32 weeks of gestation
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 13333 13475
Measure Type: Number
Unit of Measure: participants
385 291
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.62 to 0.86
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
8.Secondary Outcome
Title Moderate to Late Preterm
Hide Description Risk of birth between 32 and 37 weeks gestation
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 1333 13475
Measure Type: Number
Unit of Measure: participants
2391 2113
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.81 to 0.93
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
9.Secondary Outcome
Title Low Birth Weight
Hide Description Birth weight below 2500g
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 10530 10642
Measure Type: Number
Unit of Measure: participants
4809 4275
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate, Multiple Micronutrient
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Bonferroni-adjusted alpha=0.01 (for 5 comparisons)
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.85 to 0.91
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
10.Secondary Outcome
Title Small for Gestation Age
Hide Description Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
Time Frame December 2014
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron and Folate Multiple Micronutrient
Hide Arm/Group Description:

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Overall Number of Participants Analyzed 10099 10161
Measure Type: Number
Unit of Measure: participants
6479 6405
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iron and Folate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Regression, Logistic
Comments Bonferroni-adjusted alpha=0.01 (for 5 comparisons)
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.96 to 1.01
Estimation Comments GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iron (27 mg) and Folic Acid (600 ug) Multiple Micronutrient
Hide Arm/Group Description

Iron (27 mg) and folic acid (600 ug)

Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrient

Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

All-Cause Mortality
Iron (27 mg) and Folic Acid (600 ug) Multiple Micronutrient
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Iron (27 mg) and Folic Acid (600 ug) Multiple Micronutrient
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22114 (0.00%)   0/22346 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iron (27 mg) and Folic Acid (600 ug) Multiple Micronutrient
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22114 (0.00%)   0/22346 (0.00%) 
The study was run in an area where iron deficiency rates were low.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keith P. West, Jr.
Organization: JHSPH
Phone: 4109552061
EMail: kwest@jhsph.edu
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Keith P. West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00860470     History of Changes
Other Study ID Numbers: JHU_IRB 570
First Submitted: March 11, 2009
First Posted: March 12, 2009
Results First Submitted: May 7, 2015
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015