ABSTRACT
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.
ABSTRACT
Objectives: Small-quantity lipid-based nutrient supplement (SQ-LNS) is a promising home fortification product to supplement young children's diets, but the optimal zinc level to include is uncertain. We assessed growth and development in young Burkinabe children who received SQLNS without or with varied amounts of zinc. Methods: In a partially masked, placebo-controlled, randomized trial, 34 communities were assigned to immediate (II) or non-intervention (NI). 2469 eligible II children were randomly assigned to 1 of 4 groups to receive 20 g LNS/d containing 0, 5 or 10 mg of zinc (and placebo tablet) or LNS without zinc and 5 mg zinc tablet from 9-18 mo of age, along with treatment of malaria and diarrhea. Children in NI (n=797) received neither SQ-LNS, tablets nor morbidity treatment. At 9 and 18 mo, length, weight, and mid-upper arm circumference (MUAC) were measured in all children. In a randomly selected subgroup, motor, language, and personal-social development was assessed at 18 mo (n=747 II; n=376 DI). Results: Reported adherence was 97±5% for SQ-LNS and tablets. Length, weight, MUAC and developmental scores were significantly greater at 18 mo in children who received SQ-LNS and morbidity treatment (p<0.001) compared to NI, but did not differ by II group. Stunting prevalence at 18 mo was 39% in children in NI and significantly reduced to 24-33% in children in the II groups (p<0.0001). Conclusions: Providing daily 20 g LNS with or without zinc along with malaria and diarrhea treatment significantly improved growth and motor, language, and personal-social development in young children.
ABSTRACT
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.