Trial Outcomes & Findings for Randomized Trial of Vitamin B12 in Pregnant Indian Women (NCT NCT00641862)

NCT ID: NCT00641862

Last Updated: 2020-07-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 366 participants
• Primary outcome timeframe: from 1st to 3rd trimester
• Results posted on: 2020-07-28

Participant Flow

Participant milestones

Measure	Vitamin B12 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: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Overall Study STARTED	183	183
Overall Study COMPLETED	139	145
Overall Study NOT COMPLETED	44	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial of Vitamin B12 in Pregnant Indian Women

Baseline characteristics by cohort

Measure	Vitamin B12 n=183 Participants 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 n=183 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery	Total n=366 Participants Total of all reporting groups
Age, Continuous	22 years n=5 Participants	22 years n=7 Participants	22 years n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	183 Participants n=7 Participants	366 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: from 1st to 3rd trimester

Population: Serum samples were available for analysis among 102 of the original 183 participants in each arm.

Outcome measures

Measure	Vitamin B12 n=102 Participants 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 n=102 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester	3.0 pmol/L Interval -54.8 to 83.5	-37.6 pmol/L Interval -66.5 to -10.9

SECONDARY outcome

Timeframe: 9 months

Population: Outcome was measured among 178 of the 366 enrolled participants.

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.

Outcome measures

Measure	Vitamin B12 n=78 Participants 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 n=100 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Cognitive Scale, Bayley Scales of Infant Development, 3rd Edition	39 units on a scale Interval 37.0 to 41.0	39.5 units on a scale Interval 38.0 to 42.0

SECONDARY outcome

Timeframe: 9 months

Population: This outcome was measured among 178 of the 366 enrolled participants.

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.

Outcome measures

Measure	Vitamin B12 n=78 Participants 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 n=100 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Receptive Language Scale, Bayley Scales of Infant Development, 3rd Edition	11 units on a scale Interval 11.0 to 12.0	11 units on a scale Interval 11.0 to 12.0

SECONDARY outcome

Timeframe: 9 months

Population: This outcome was measured in 178 of the 366 enrolled participants

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.

Outcome measures

Measure	Vitamin B12 n=78 Participants 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 n=100 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Expressive Language Scale, Bayley Scales of Infant Development, 3rd Edition	10 units on a scale Interval 9.0 to 12.0	11 units on a scale Interval 9.0 to 12.0

SECONDARY outcome

Timeframe: 9 months

Population: This outcome was measured in 178 of the original 366 participants

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.

Outcome measures

Measure	Vitamin B12 n=78 Participants 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 n=100 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Fine Motor Scale, Bayley Scales of Infant Development, 3rd Edition	26 units on a scale Interval 25.0 to 27.0	26 units on a scale Interval 25.0 to 27.0

SECONDARY outcome

Timeframe: 9 months

Population: This outcome was measured in 178 of the 366 enrolled participants

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.

Outcome measures

Measure	Vitamin B12 n=78 Participants 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 n=100 Participants Placebo Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
Gross Motor Scale, Bayley Scales of Infant Development, 3rd Edition	36 units on a scale Interval 31.0 to 38.0	34 units on a scale Interval 30.0 to 38.0

SECONDARY outcome

Timeframe: 60-72 months

This test is used for assessing child intelligence

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 78 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60-72 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 66 months postpartum

The Brief P test is a measure of infant executive function based on parental rating. It will be administered at 66 months postpartum.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 78 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Vitamin B12

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Christopher Duggan

Harvard T.H. Chan School of Public Health

Phone: 617-355-7612

Email: christopher.duggan@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place