Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07863050
NA

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

Sponsor: EllaOla

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

4 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2026-10-14

Completion Date

2027-05-19

Last Updated

2026-10-07

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

EllaOla Kids Essentials Unflavored Powdered Multivitamin

An unflavored, powdered children's multivitamin. Each serving provides vitamins A, C, D3 (20 mcg), E, K2, B1, B3, B5, B6, B12 (2 mcg), folate, and biotin, plus iodine, zinc, selenium, manganese, and a fruit and vegetable blend, in a tapioca fiber base with monk fruit. Parents/caregivers give one full serving once daily in the morning, mixed into at least 2 ounces of juice or milk, for 12 weeks. Participants who opt into the open-label extension continue daily use through Week 24.

DIETARY_SUPPLEMENT

Placebo (Tapioca Fiber)

A tapioca fiber powder with no vitamins or minerals, matched to the study product in appearance, packaging, and labeling. Parents/caregivers give one full serving once daily in the morning, mixed into at least 2 ounces of juice or milk, for the 12-week double-blind period. Used as Placebo comparator only.