Micronutrient interventions to improve infant neurocognitive development and growth in early infancy
- Conditions
- Infant neurocognitive development and growthNot Applicable
- Registration Number
- ISRCTN15063705
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 600
1. Pregnant women aged 18-49 years
2. Singleton pregnancy at <20 weeks gestation at initial pregnancy confirmation
3. Healthy, with no evidence of current severe anaemia (haemoglobin >7 g/dl)
4. Willingness to take a daily trial product (capsule) daily from 20 weeks of pregnancy until 6 months post-partum and for their infant to receive a daily trial product (syrup drops) from Day 8 until 6 months of age
Pregnancy:
1. Multiple pregnancy
2. Pregnancy =20 weeks gestation
3. Severe anaemia (haemoglobin <7 g/dl)
4. Any history or evidence of chronic disease (including HIV, TB, hypertension)
5. Unwilling to avoid the ingestion of other micronutrient supplements during the study period
Post-partum/infancy:
1. Very or extremely preterm infants (< 32 weeks gestation at delivery)
2. Very low birth weight infants (<1.5 kg at delivery)
3. Infants identified at any follow-up point as having severe-acute malnutrition (weight-for-height z score of <-3SD)
4. Non-breastfeeding mother-infant pairs
5. Unwilling to avoid the ingestion of – or for their infant to avoid the ingestion of – other micronutrient supplements during the study period
6. Any condition of the mother or infant that, in the opinion of the investigator, might compromise the safety or well-being of the participant or compromise adherence to protocol procedures (including the identification of severe neurodevelopmental conditions, such as cerebral palsy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method