Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants fulfilling all of the following inclusion criteria are eligible for the study: Study 1: - Pregnant women (= 18 years of age) with gestational age =20 weeks - Written Informed Consent as documented by signature Study 2: - Children 6-35 months of age at recruitment - Written Informed Consent as documented by signature
Exclusion criteria
Exclusion criteria: Study 1: - If a family does not intend to stay within the study area for at least the following 30 months - Known history of allergy towards peanut or milk products - Visible severe disease Study 2: - A family does not intend to stay within the study area for at least the following 24 months - Visible severe disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome-change in Length for Age Z scores between birth and 24 months of age in study 1 and over the course of the 2 years programme activity in study 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome- Blood-based secondary outcomes measured in children in study 1 include: Haemoglobin concentration measured at birth and 6 and 24 months of age will be used to assess the change in haemoglobin concentration and proportion with anaemia (Hb< 11g/dL). SF (serum ferritin), CRP (C-reactive protein) and AGP (alpha 1- acid glycoprotein) measured at 6 and 24 months of age will be used to assess the proportion with inflammation-adjusted iron deficiency (SF<12 µg/L) and the change in proportion with inflammation-adjusted iron deficiency. RBP (retinol-binding protein), CRP and AGP measured at 6 and 24 months of age will be used to assess the proportion with inflammation-adjusted vitamin A deficiency (RBP<0.7 µmol/L) and the change of proportion with inflammation-adjusted vitamin A deficiency. Blood-based secondary outcomes measured in pregnant women include- Haemoglobin concentration measured at 34 weeks gestation and 6 months postpartum will be used to assess the change in haemoglobin concentration, the proportion with anaemia (Hb < 11 g/dL), and the change in the proportion with anaemia. SF, CRP and AGP measured at 34 weeks gestation will be used to assess the proportion with inflammation-adjusted iron deficiency (SF<15 µg/L). RBP, CRP and AGP measured at 34 weeks gestation will be used to assess the proportion with inflammation-adjusted vitamin A deficiency (RBP<0.7 µmol/L). | — |
Countries
Kenya
Contacts
CoPI and liaison officer