Optimisation of nutritional status for immune development Pregnancy and Childbirth
Conditions
Interventions
Four pregnancy interventions, to be given daily from 12 weeks gestation until delivery:
1. FeFol: Iron-folate, 60 mg iron 400 µg folate, representing the usual standard of care during
Sponsors
Medical Research Council (MRC) (UK) - International Nutrition Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Amended as of 04/10/2010: Women (aged 18 to 45 years) resident in Kiang West Region, The Gambia, with pregnancy confirmed by urine test and ultrasound examination and with gestational age approximately 10 - 20 weeks. Initial information at time of registration: Women (aged 18 to 45 years) resident in Kiang West Region, The Gambia, with pregnancy confirmed by urine test and ultrasound examination and with gestational age approximately 12 weeks
Exclusion criteria
Exclusion criteria: Amended as of 04/10/2010: 1. Currently enrolled in another MRC study or current pregnancy (beyond 20 weeks on ultrasound assessment) 2. Severe anaemia (haemoglobin [Hb] less than 7 g/dL) 3. Reported onset of menopause Initial information at time of registration: 1. Currently enrolled in another MRC study or current pregnancy (beyond 12 weeks on ultrasound assessment) 2. Severe anaemia (haemoglobin [Hb] less than 7 g/dL) 3. Reported onset of menopause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Thymic index at 1, 8, 24 and 52 weeks of age 2. Antibody response to EPI vaccines (diphtheria, tetanus toxoid, HiB, measles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cellular markers of immunity in a randomly selected sub-cohort of infants, stratified by treatment group. The secondary outcome measurements will be assessed when the infants are 12, 24 and 52 weeks of age. | — |
Countries
Gambia
Outcome results
None listed