Background: The Mycotoxin Mitigation Trial (MMT) was a community-based cluster-randomized trial designed to assess the effect of dietary aflatoxin (AF) on linear growth. Similar dietary intake between arms was an important component of the trial's program theory and essential for the trial's internal validity and interpretation.
Objective: This analysis assessed and compared dietary intake by arm within a sub-sample of infants enrolled in the MMT.
Methods: Twenty paired clusters (10 per trial arm) out of the 52 MMT clusters were included in this sub-sample. Up to 15 maternal/infant dyads per cluster were randomly selected for a one-time, structured, multi-pass 24 h dietary recall. Data were collected at the midpoint of the trial, when infants were 12 months of age, over 8 calendar months. We evaluated and compared infant nutrient intake and adequacy of energy, protein, lipid, iron, zinc, calcium, and vitamin A between study arms. Nutrient intake by arm was estimated using mixed-level regression models.
Results: A total of 282 mothers participated (n = 140 intervention arm and 142 standard of care (SoC) arm). The mean daily intakes of energy and lipid fed to infants were 505 kcal/day (SD = 225.9) and 13 g/day (SD = 6.9), respectively, in the intervention and SoC arms, with no difference between arms. Intervention infants consumed slightly more protein than SoC infants (13.7 v. 12.3 g/day, p = 0.02). Consumption of iron, zinc, calcium, and vitamin A were low and did not differ between arms.
Conclusions: At the midpoint of the MMT, energy, lipid, and micronutrient intake did not differ between arms. Protein consumption was slightly greater in the intervention arm. Guided by the trial's program theory, this analysis advances the interpretation of the MMT trial findings.
Keywords: 24 h dietary recalls; complementary feeding; nutrient intake.