PACTR202201552774601
Not yet recruiting
Phase 3
Micronutrient interventions to improve infant neurocognitive development and growth in early infancy
Kings College London0 sites1,200 target enrollmentOctober 26, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kings College London
- Enrollment
- 1200
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnancy \< 20 weeks at initial pregnancy confirmation
- •Singleton pregnancy
- •Healthy, with no evidence of current severe anaemia
- •Willingness to take a daily trial product (capsule) daily from 20 weeks of pregnancy until six\-months post\-partum and for their infant to receive a daily trial product (syrup drops) from Day 8 until 6 months of age
- •Intention to remain resident in West or Central Kiang until the infant is 12 months of age
Exclusion Criteria
- •Pregnancy phase:
- •Multiple pregnancy
- •Pregnancy \=20 weeks gestation
- •Severe anaemia (\<7g/dL)
- •Any known history or evidence of chronic disease (including HIV, TB, non\-pregnancy\-induced\-hypertension or diabetes). Women will be offered HIV Voluntary Counselling and Testing (as part of routine antenatal care) and, where positive, excluded from the trial
- •Unwilling to avoid the ingestion of other micronutrient supplements during the study period
- •If the primary language of the mother is not Mandinka or Fula
- •Post\-partum / Infancy phase:
- •Very or extremely preterm infants (\< 32 weeks gestation at delivery)
- •Very low birth weight infants (\<1\.5kg at delivery)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Child of Urban Poverty Iron Project (CUPIP) - A Pilot StudyIron-deficiencyIron Deficiency AnemiaMicronutrient DeficiencyNutrient DeficiencyStuntingNCT03819530University of Malaya45
Completed
Not Applicable
A follow up study to examine the effects of infant milk cereal supplements during infancy on neurodevelopment at 12 and 24 months of ageCTRI/2019/03/018238Centre for Health Research and Development Society for Applied Studies1,214
Recruiting
Not Applicable
The Taiora Trial: A community-based randomized placebo-controlled trial evaluating micronutrients for emotion dysregulation in teenagers experiencing mood problemsACTRN12621000399897Professor Julia Rucklidge150
Completed
Not Applicable
Micronutrient supplementation in metabolic syndromeMetabolic SyndromeMetabolic and Endocrine - Metabolic disordersACTRN12621000678897niversity of Otago, Dunedin72
Active, not recruiting
Phase 2
Optimising micronutrient status in toddlers - putting the theory into practiceMicronutrient status of toddlersDiet and Nutrition - Other diet and nutrition disordersACTRN12605000487617niversity of Otago225