Table 1.
Overview of study populations, study period and exposure in the original trials and in the Vitabeginning follow-up study
Characteristics | Bangalore | Delhi | Dares Salaam | |
Original trials | ||||
Trial registration number | NCT00641862 | NCT00717730 | NCT00197548 | NCT00421668 |
Intervention period | 09.2010–08.2011 | 01.2010–03.2011 | 08.2001–02.2005 | 07.2007–05. 2011 |
Original sample size | 366 | 1000 | 8468 | 2400 |
Exposure | Vitamin B12* | Vitamin B12 and/or folic acid† | Maternal multivitamins‡ | Multivitamins and/or zinc§ |
Timing of exposure | Pregnancy (daily supplement from <14 weeks gestational age through 6-week postpartum) | Infancy/early childhood (daily supplement for 6 months from 6 to 30 months) | Pregnancy (daily supplement from 11-17 weeks until delivery) | Infancy (daily supplement from 6 weeks to 18 months) |
Vitabeginning follow-ups | ||||
Expected sample size | 230 | 800–900 | 366 | 446 |
Age range at follow-up | 5–6.5 years | 7–9 years | 11–15 years | 7–10 years |
Start date of enrolment | 01.2015 | 10.2016 | 07.2015 | 07.2015 |
Expected date for study completion | Estimated 07.2017 | Estimated 11.2017 | Estimated 11.2017 | Estimated 11.2017 |
*From <14 weeks gestational age to 6 weeks postpartum vitamin B12 50 µg daily. In addition, all women were given iron and folic acid supplementation throughout pregnancy.
†From 6 to 30 months for 6 months; four groups: vitamin B12, vitamin B12 +folic acid, folic acid and placebo, doses >12 months: vitamin B12 1.8 µg and folic acid 150 µg (half doses for <12 months).
‡From 12 to 27 weeks gestational age until delivery: multivitamin B12 50 µg, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, niacin 100 mg, vitamin C 500 mg, vitamin E 30 mg, folic acid 0.8 mg.
§From 6 weeks to 18 months, four groups; multivitamin + zinc, vitamin Z and placebo. Multivitamin <6m: vitamin B12 1 mg, vitamin B1 0.5 mg, vitamin B2 0.6 mg, vitamin B 60.6mg, niacin 4 mg, folic acid 130 µg, vitamin C 60 mg, vitamin E 8 mg. Zinc 5 mg >6 months multivitamins and zinc doses were double.