Clinical Research Directory

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of an Unflavored Powdered Multivitamin on Behavior and Overall Health in Children Aged 4-11 Years

The goal of this clinical trial is to learn whether a daily unflavored powdered multivitamin (EllaOla Kids Essentials) improves mood and behavior in children aged 4 to 11 who are picky eaters and experience behavioral challenges. Researchers will also look at whether the multivitamin affects overall health, well-being, nutrition, and serum vitamin levels, and whether it is safe and well tolerated. The main questions it aims to answer are: Do more parents of children taking the multivitamin report a clinically meaningful improvement in their child's overall mood and behavior after 12 weeks than parents of children taking a placebo? Does the multivitamin change parent-reported emotional reactivity, overall health and well-being, and nutrition over 12 weeks? In children who take part in optional at-home blood testing, does the multivitamin improve serum vitamin D and vitamin B12 levels? Researchers will compare the multivitamin to a placebo (a look-alike powder made of tapioca fiber that contains no vitamins) to see if it improves mood and behavior. Participants will: Be randomly assigned to receive either the multivitamin or the placebo. Neither the families nor the study team will know which one the child gets. Have a parent or caregiver mix the powder into the child's food or drink once a day at home for 12 weeks. Have a parent or caregiver complete short online questionnaires about the child's mood, behavior, health, and nutrition at baseline and at Weeks 2, 4, 6, 8, and 12, using a smartphone app. All study visits are remote. Choose whether to do an optional at-home blood collection at the start and at Week 12. Choose whether to continue in an optional 12-week open-label extension (Weeks 12-24), where all children, including those who were on placebo, receive the multivitamin.