Comparison of Methods to Assess Adherence to Small-quantity Lipid Based Nutrient Supplements (SQ-LNS) and Dispersible Tablets among Young Burkinabe Children Participating in a Community-based Intervention Trial.

Objectives: Adherence to supplementation provided during an intervention trial can affect study outcomes. We compared different approaches for estimating adherence to SQ-LNS and dispersible tablets in a randomized clinical trial in Burkina Faso to evaluate concordance among results and factors associated with reported non-adherence. Methods: 2453 children (9-18 mo) were randomly assigned to receive daily 20 g SQ-LNS with varying contents of zinc and a dispersible tablet (0 or 5mg zinc). During weekly home visits, reported adherence to SQ-LNS and tablets was collected through caregiver interview and disappearance rate was calculated based on unused packages. In a randomly selected subgroup (n=192), 12-h home observations were completed when children were 11 and 16 mo of age, to assess supplement consumption. Results: Average daily reported SQ-LNS and tablet adherence was 97%±6%. SQ-LNS and tablet disappearance rate also showed high weekly adherence (98%±5%). By contrast, home observation found that only 68% and 58% of children at 11 and 16-mo, respectively, received SQLNS during the observation periods (Rho=0.06, P=0.294 reported vs. observed), and fewer (36 and 28%) received a tablet at 11 and 16-mo (Rho=0.11, P=0.05). Fever, diarrhea, malaria, vomiting and loss of appetite reduced significantly reported consumption of SQ-LNS and, to a lesser extent, tablet (P<0.0001). Conclusions: Discrepancies among observed and reported results suggest possible overreporting of adherence to products and/or that consumption occurs outside the 12h home observation period. Child morbidity may change child acceptance or caregiver perceptions regarding the suitability of supplementation. Better methods are needed to assess adherence in community supplementation trials.

Malaria Infection Affects the Interpretation of Biomarkers of Iron and Vitamin A Status, Even After Adjusting for Systemic Inflammation, but Does Not Affect Plasma Zinc Concentrations.

Objectives: To assess how asymptomatic malaria infection affects the interpretation of biomarkers of iron, vitamin A and zinc status after adjustment for elevated acute phase proteins (APP). Methods: Plasma ferritin (pF), transferrin receptor (sTfR), retinol binding protein (RBP) and zinc (pZn) concentrations were measured among 451 asymptomatic children aged 6-23 months in Burkina Faso, and adjusted for elevated APP (C-reactive protein ≥5 mg/L and/or alpha-1-acidglycoprotein ≥1g/L) based on a four-group categorical model, as per Thurnham. Histidine-rich protein II (HRP2) concentrations >0.75 ng/mL were considered indicative of current or recent malaria parasitemia. Results: 57.4% of children had at least one elevated APP, and 48.5% had elevated HRP2. After adjusting for APP, children with elevated HRP2 had higher pF (23.5+1.5 vs. 11.1+0.8 μg/L, P<0.001) and lower RBP (0.79+0.01 vs. 0.92+0.01 μmol/L, P<0.001) vs. those without. Controlling for APP, there were no differences in pZn among those with and without elevated HRP2 (62.9+0.8 vs. 62.9+0.8 μg/dL, P=0.98). sTfR did not differ by APP status when controlling for HRP2, but was increased in children with elevated HRP2 vs. those without (17.6+0.5 vs. 12.3+0.4mg/L, P<0.0001). After adjusting for HRP2, along with APP, the estimated prevalence of iron deficiency (pF<12 μg/L) increased from 38.7% to 50.6% and vitamin A deficiency (RBP<0.84μmol/L) decreased from 33.4% to 27.7%. Conclusions: Current or recent malaria parasitemia affects indicators of micronutrient status, even after adjusting for APP. Adjusting indicators of iron and vitamin A status based only on APP may inaccurately estimate the prevalence of micronutrient deficiencies in settings with a high prevalence of malaria and inflammation.

Zinc added in Different Amounts to Small-quantity Lipid-based Nutrient Supplements (SQ-LNS) or provided as a Tablet did not affect Diarrhea or Malaria Morbidity in young, Rural Burkinabe Children.

Objectives: Meta-analyses find that supplemental zinc reduces the incidence of diarrhea and acute lower respiratory tract infections, but its effect on malaria is inconsistent. We assessed the effects of different amounts of zinc in SQ-LNS compared with zinc in a dispersible tablet on the incidence of diarrhea and malaria in young children in a community-based, double-blind, placebo controlled, randomized trial in rural, southwestern Burkina Faso. Methods: 2469 children 9 months of age, were assigned to receive one of four interventions: LNS without zinc and placebo tablet (LNS-Zn0; negative control), LNS with 5 mg zinc and placebo tablet (LNS-Zn5), LNS with 10 mg zinc and placebo tablet (LNS-Zn 10) and LNS without zinc and 5 mg zinc tablet (LNS-TabZn5; positive control). Children received 20 g of LNS and one placebo or zinc tablet daily for 9 months. Weekly morbidity surveillance was conducted at children's homes; malaria treatment was provided for confirmed malaria, and ORS provided for reported diarrhea. Results: Prevalence of malaria at baseline (59.4% overall) did not differ among groups. During the 9-month follow-up, the incidence of diarrhea was 1.15 (±1.18 SD) and the incidence of malaria was 0.55 (±0.54 SD) episodes per 100 child-days, and did not differ by treatment group (p=0.673 and p=0.535, respectively). Incidence of severe diarrhea and severe malaria also did not differ by treatment group. Conclusions: The inclusion of 5 or 10 mg zinc in SQ-LNS did not affect diarrhea or malaria morbidity compared to both positive and negative control groups in this population.