N/A
N=366
Randomized Trial of Vitamin B12 in Pregnant Indian Women
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00641862 ↗Enrolled (actual)
366
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester — 3.0; -37.6 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin B12 (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Harvard School of Public Health (HSPH)
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester |
3.0; -37.6 | — |
| SECONDARY Cognitive Scale, Bayley Scales of Infant Development, 3rd Edition |
39; 39.5 | — |
| SECONDARY Receptive Language Scale, Bayley Scales of Infant Development, 3rd Edition |
11; 11 | — |
| SECONDARY Expressive Language Scale, Bayley Scales of Infant Development, 3rd Edition |
10; 11 | — |
| SECONDARY Fine Motor Scale, Bayley Scales of Infant Development, 3rd Edition |
26; 26 | — |
| SECONDARY Gross Motor Scale, Bayley Scales of Infant Development, 3rd Edition |
36; 34 | — |
| SECONDARY Kaufman's Assessment Battery for Children (KABC) |
— | — |
| SECONDARY The Wechsler Preschool and Primary Scale of Intelligence (WPPSI) |
— | — |
| SECONDARY Vineland Social Maturity Scale (VSMS) |
— | — |
| SECONDARY The Brief P Test |
— | — |
| SECONDARY Parental Version of Strengths and Difficulties Questionnaire (SDQ) |
— | — |
| SECONDARY Bradley Infant-Toddler Home Tools |
— | — |
Summary
This study is a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status. Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.
Eligibility Criteria
Inclusion Criteria
- Pregnant women at or before 14 weeks gestational age.
Exclusion Criteria
- Women who anticipate moving outside of the study area before study completion
- Those with twin or multiple pregnancies
- Those who test positive for hepatitis B (HepBSAg), HIV or Syphilis (VDRL)
- Those taking vitamin supplements in addition to folate and iron
- Those with a serious pre-existing medical condition, defined as conditions that require chronic or daily medical therapy such as connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin dependent diabetes.
Data sourced from ClinicalTrials.gov (NCT00641862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.