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Randomized Trial of Vitamin B12 in Pregnant Indian Women (B12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641862
Recruitment Status : Active, not recruiting
First Posted : March 24, 2008
Results First Posted : October 17, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
St. John's Research Institute
Information provided by (Responsible Party):
Christopher Duggan, Harvard 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: Treatment
Condition Pregnancy
Interventions Dietary Supplement: Vitamin B12
Other: Placebo
Enrollment 366
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Period Title: Overall Study
Started 183 183
Completed 139 145
Not Completed 44 38
Arm/Group Title Vitamin B12 Placebo Total
Hide Arm/Group Description

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Total of all reporting groups
Overall Number of Baseline Participants 183 183 366
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 183 participants 183 participants 366 participants
22
(20 to 24)
22
(20 to 24)
22
(20 to 24)
[1]
Measure Description: We confirm that the median and inter-quartile ranges listed here are correct
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 183 participants 366 participants
Female
183
 100.0%
183
 100.0%
366
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester
Hide Description [Not Specified]
Time Frame from 1st to 3rd trimester
Hide Outcome Measure Data
Hide Analysis Population Description
Serum samples were available for analysis among 102 of the original 183 participants in each arm.
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description:

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Overall Number of Participants Analyzed 102 102
Median (Inter-Quartile Range)
Unit of Measure: pmol/L
3.0
(-54.8 to 83.5)
-37.6
(-66.5 to -10.9)
2.Secondary Outcome
Title Cognitive Scale, Bayley Scales of Infant Development, 3rd Edition
Hide Description The cognitive scale is a single scale that measures sensorimotor integration, concept formation, attention, habituation, and memory. Higher values represent better performance. The interquartile range provides an adequate assessment of the variability of the data. The minimum possible score of the cognitive scale is 0 and the maximum possible score is 91.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome was measured among 178 of the 366 enrolled participants.
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description:

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Overall Number of Participants Analyzed 78 100
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
39
(37 to 41)
39.5
(38 to 42)
3.Secondary Outcome
Title Receptive Language Scale, Bayley Scales of Infant Development, 3rd Edition
Hide Description The Receptive Language Scale is a single scale that measures the ability of the child to recognize sounds and understand spoken words and directions. Higher values represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible score is 0 and the maximum possible score is 49.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was measured among 178 of the 366 enrolled participants.
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description:

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Overall Number of Participants Analyzed 78 100
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
11
(11 to 12)
11
(11 to 12)
4.Secondary Outcome
Title Expressive Language Scale, Bayley Scales of Infant Development, 3rd Edition
Hide Description The Expressive Language Scale is a single scale that measures the ability of the child to communicate using sounds, gestures, or words. Higher scores represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible value is 0 and the maximum possible value is 48.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was measured in 178 of the 366 enrolled participants
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description:

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Overall Number of Participants Analyzed 78 100
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
10
(9 to 12)
11
(9 to 12)
5.Secondary Outcome
Title Fine Motor Scale, Bayley Scales of Infant Development, 3rd Edition
Hide Description The Fine Motor Scale is a single scale that measures prehension, perceptual-motor integration, motor planning and speed, visual tracking, reaching, object grasping, object manipulation, functional hand skills, and responses to tactile information. Higher values represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible value is 0 and the maximum possible value is 66.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was measured in 178 of the original 366 participants
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description:

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Overall Number of Participants Analyzed 78 100
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
26
(25 to 27)
26
(25 to 27)
6.Secondary Outcome
Title Gross Motor Scale, Bayley Scales of Infant Development, 3rd Edition
Hide Description The Gross Motor Scale is a single scale that measures movement of the limbs and torso, static positioning (e.g., sitting, standing), dynamic movement including locomotion and coordination, balance, and motor planning. Higher values represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible value is 0 and the maxiumum possible value is 72.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was measured in 178 of the 366 enrolled participants
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description:

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Overall Number of Participants Analyzed 78 100
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
36
(31 to 38)
34
(30 to 38)
7.Secondary Outcome
Title Kaufman's Assessment Battery for Children (KABC)
Hide Description This test is used for assessing child intelligence
Time Frame 60-72 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title The Wechsler Preschool and Primary Scale of Intelligence (WPPSI)
Hide Description WPPSI is an intelligence test designed for children ages 2 years 6 months to 7 years 7 months. It is a paper-pencil test that will be administered during the 78 month follow up to assess child's intellectual functioning.
Time Frame 78 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Vineland Social Maturity Scale (VSMS)
Hide Description This scale has 8 main domains which include, Self Help General, Self Help Dressing, Self Direction, Occupation, Communication, Locomotion and Socialization. It is possible to calculate Social age and Social quotient from VSMS which will provide a good idea about the social maturity of the infant. VSMS will be used in conjunction with KABC at age 60-72 months of age.
Time Frame 60-72 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title The Brief P Test
Hide Description The Brief P test is a measure of infant executive function based on parental rating. It will be administered at 66 months postpartum.
Time Frame 66 months postpartum
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Parental Version of Strengths and Difficulties Questionnaire (SDQ)
Hide Description Administered at 78 months to assess childhood behavioral problems. The SDQ has 25 items and generates 5 scales: emotional problem, conduct problem, hyperactivity/inattention, peer relationship problems and pro-social behavior.
Time Frame 78 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Bradley Infant-Toddler Home Tools
Hide Description Home tools used to analyze aspects of home environment. This scale captures information on parenting behavior under 6 domains: responsivity, acceptance, organization, learning materials, parental involvement, and variety of stimulation at home). Trained study personnel will administer this questionnaire to participating families at 60 months.
Time Frame 60 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin B12 Placebo
Hide Arm/Group Description

Vitamin B12

Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

All-Cause Mortality
Vitamin B12 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin B12 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)   0/183 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin B12 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)   0/183 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher Duggan
Organization: Harvard T.H. Chan School of Public Health
Phone: 617-355-7612
EMail: christopher.duggan@childrens.harvard.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christopher Duggan, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00641862     History of Changes
Other Study ID Numbers: HD052143
First Submitted: March 17, 2008
First Posted: March 24, 2008
Results First Submitted: August 22, 2016
Results First Posted: October 17, 2016
Last Update Posted: March 8, 2019