Unflavored Powdered Multivitamin in Children

• EllaOla Kids Essentials Unflavored Powdered Multivitamin (Dietary supplement), also known as EllaOla Kids Essentials, Study Product: 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.
• Placebo (Tapioca Fiber) (Dietary supplement), also known as Matching Placebo: 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.

Primary outcomes

• Proportion of PGI-C Responders on the Overall Mood and Behavior Item [Week 12]: Proportion of participants rated by their parent/caregiver as "very much improved" (1) or "much improved" (2) on the Overall Mood and Behavior item of the Parent Global Impression of Change (PGI-C). The PGI-C is rated on a 7-point scale (1 = very much improved; 4 = no change; 7 = very much worse). Lower scores indicate greater improvement.

Secondary outcomes

• Proportion of PGI-C Responders on the Overall Mood and Behavior Item Over Time [Weeks 2, 4, 6, 8, and 12]: Proportion of participants rated "very much improved" (1) or "much improved" (2) on the PGI-C Overall Mood and Behavior item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change.
• Proportion of PGI-C Improvers on the Overall Mood and Behavior Item [Weeks 2, 4, 6, 8, and 12]: Proportion of participants rated "very much improved" (1), "much improved" (2), or "minimally improved" (3) on the PGI-C Overall Mood and Behavior item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change.
• Mean PGI-C Overall Mood and Behavior Score [Weeks 2, 4, 6, 8, and 12]: Mean parent-rated score on the PGI-C Overall Mood and Behavior item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change. Lower scores indicate greater improvement.
• Change From Baseline in Serum 25-Hydroxyvitamin D [25(OH)D] (Blood Work Subgroup) [Baseline and Week 12]: Change from baseline in serum 25(OH)D in the optional blood work subgroup. Samples are collected at home with the Tasso Mini device.
• Change From Baseline in Serum Vitamin B12 (Blood Work Subgroup) [Baseline and Week 12]: Change from baseline in serum vitamin B12 in the optional blood work subgroup. Samples are collected at home with the Tasso Mini device.
• PGI-C Overall Health and Well-being: Responder Proportion and Mean Score [Weeks 2, 4, 6, 8, and 12]: Proportion of participants rated "very much improved" (1) or "much improved" (2), and the mean score, on the PGI-C Overall Health and Well-being item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change. Lower scores indicate greater improvement.
• PGI-C Overall Nutrition: Responder Proportion and Mean Score [Weeks 2, 4, 6, 8, and 12]: Proportion of participants rated "very much improved" (1) or "much improved" (2), and the mean score, on the PGI-C Overall Nutrition item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change. Lower scores indicate greater improvement.
• PGI-C Mood and Behavior Domain Composite Score [Weeks 2, 4, 6, 8, and 12]: Mean of the two PGI-C Mood and Behavior domain items (tantrums/meltdowns and mood), along with the individual item scores. Each item is rated on a 7-point scale from 1 = very much improved to 7 = very much worse, with 4 = no change. Lower scores indicate greater improvement.
• Change From Baseline in Emotion Dysregulation Inventory (EDI) Reactivity Score [Baseline, Weeks 4, 8, and 12]: Change from baseline in the parent-reported EDI Reactivity Index score. The EDI-Young Child is used for ages 4-5 and the standard EDI for ages 6-11. Items are rated on a 5-point scale (0 = not at all to 4 = very severe) over the past 7 days. Higher scores indicate poorer emotion regulation.

Sex: All, ages: 4 Years to 11 Years, accepts healthy volunteers

Inclusion Criteria:

1. Healthy child aged 4-11 years at time of enrollment, male or female
2. Not currently taking oral over-the-counter supplements or another multivitamin, if they are taking, must discontinue use for at least four weeks prior to randomization and for the duration of the study.
3. Parent reports active concern/challenge in behavior and selective eating confirmed by minimum threshold scores on three screening instruments: a. Selective Eating: </= 3 on the Selective Eating Screening Tool Section A and at least two behavioral anchors Q11 = concern about child's nutrition "3-4 days per week or 5-7 days per week), Q12 = "fewer than 20 foods" (10-19 or fewer than 10), Q13 = refusal of ≥ 1 whole food group b. Behavior: Participants must meet both of the following criteria: 1. EDI Reactivity T-score ≥ 60 (for EDI or EDI-YC dependent on age of child); indicating elevated emotional reactivity relative to age-based norms (general population norms); -AND- 2. Behavioral Screening Tool: Evidence of clinically meaningful baseline difficulty in behavior and emotional regulation, defined as: ○ A rating of "Often" or "Very Often" (score ≥ 4) on all three Mood and Behavior Difficulties screening items;
4. Generally healthy as determined by caregiver report without any chronic medical condition that is unstable is actively being treated with medication changes, or that in the judgment of the Investigator would interfere with study participation or interpretation of results.
5. Parent is willing and able to administer the study product daily and complete questionnaires at all timepoints
6. Willing and able to maintain current diet, physical activity consistently throughout the study duration.
7. Parent is able to read and understand English.
8. Parent is able to read, understand, and provide informed consent.
9. Parent is able to use a personal smartphone device and download Chloe by People Science.
10. Able to receive shipment of the product at an address within the United States.
11. Parent is able to complete study assessments over the course of up to 20 weeks.

Exclusion Criteria:

Any potential participants who:

1. Parent does not have a personal smartphone, internet access, or is unwilling to download Chloe.
2. Child does not meet minimum threshold screening scores in two domains as specified in Inclusion Criteria 3
3. Concomitant Therapies:

   1. Current use of stimulant medication, antipsychotics, or appetite-modifying medications that has been initiated or changed within 8 weeks prior to enrollment (stable, long-term use may be considered on a case-by-case basis with Investigator approval).
   2. Current use of any medication, supplement, or herbal remedy specifically targeted at behavior or appetite that has been initiated or changed within 8 weeks prior to randomization, or that the caregiver is unwilling to keep stable and unchanged for the duration of the study
   3. Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
   4. Caregiver intends to introduce any new medications, supplements, or herbal remedies targeting behavior or appetite during the study period.
4. Other Illnesses or Conditions:

   1. Diagnosed psychiatric disorders including but not limited to major depressive disorder, bipolar disorder, psychotic disorders or severe anxiety requiring medication changes or intensive treatment
   2. Hospitalization or significant acute illness within 3 months prior to randomization that, in the judgment of the Investigator, could affect study outcomes or participant safety.
   3. Planned major surgery or invasive treatment during study duration that, in the judgment of the principal investigator, would interfere with study participation or interpretation of results.
5. Known allergies or hypersensitivities to any of the study or placebo product ingredients
6. Currently enrolled in another interventional research study or plans to enroll in any other interventional research study at any point during the study's duration

   a. Only one child per household may enroll in this research at a time
7. Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator