Selective EatingBLOSSOMNCT07863050
Unflavored Powdered Multivitamin in Children
A study testing EllaOla Kids Essentials Unflavored Powdered Multivitamin in people with Selective Eating and Emotional Dysregulation, run by EllaOla.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Selective Eating, Emotional Dysregulation, Child Behavior
- What is being tested?
- EllaOla Kids Essentials Unflavored Powdered Multivitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2026to 19 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy child aged 4-11 years at time of enrollment, male or female
- 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.
- 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;
- 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.
- Parent is willing and able to administer the study product daily and complete questionnaires at all timepoints
- Willing and able to maintain current diet, physical activity consistently throughout the study duration.
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- Parent is able to read and understand English.
- Parent is able to read, understand, and provide informed consent.
- Parent is able to use a personal smartphone device and download Chloe by People Science.
- Able to receive shipment of the product at an address within the United States.
- Parent is able to complete study assessments over the course of up to 20 weeks.
Who cannot join
- Any potential participants who:
- Parent does not have a personal smartphone, internet access, or is unwilling to download Chloe.
- Child does not meet minimum threshold screening scores in two domains as specified in Inclusion Criteria 3
- Concomitant Therapies:
- 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).
- 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
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- Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
- Caregiver intends to introduce any new medications, supplements, or herbal remedies targeting behavior or appetite during the study period.
- Other Illnesses or Conditions:
- Diagnosed psychiatric disorders including but not limited to major depressive disorder, bipolar disorder, psychotic disorders or severe anxiety requiring medication changes or intensive treatment
- 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.
- 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.
- Known allergies or hypersensitivities to any of the study or placebo product ingredients
- 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
- Only one child per household may enroll in this research at a time
- 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
About this study
Official title: 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:
Read more
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.
- Conditions
- Selective Eating, Emotional Dysregulation, Child Behavior, Healthy Children (Wellness Study)
- Being tested
- EllaOla Kids Essentials Unflavored Powdered Multivitamin, Placebo (Tapioca Fiber)
- Keywords
- Multivitamin, Dietary Supplement, Micronutrients, Pediatric Nutrition, Mood and Behavior, Vitamin D, Vitamin B12, Decentralized Clinical Trial, Placebo Controlled
- Medical subject headings
- Child Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EllaOla Kids Essentials Unflavored Powdered MultivitaminDietary supplement
Also called 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 called 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Experimental: EllaOla Kids Essentials Multivitamin | Experimental | Participants receive EllaOla Kids Essentials Unflavored Powdered Multivitamin, administered daily at home by the parent/caregiver for 12 weeks (double-blind core period). Participants may opt into a 12-week open-label extension (Weeks 12-24) and continue receiving the active multivitamin. Receives: Dietary Supplement: EllaOla Kids Essentials Unflavored Powdered Multivitamin |
| Arm 2 - Placebo Comparator: Placebo (Tapioca Fiber) | Placebo comparator | Participants receive a matching placebo (tapioca fiber) of identical appearance, administered daily at home by the parent/caregiver for 12 weeks (double-blind core period). Participants may opt into a 12-week open-label extension (Weeks 12-24) and switch to the active multivitamin (delayed start). Receives: Dietary Supplement: Placebo (Tapioca Fiber) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PGI-C Responders on the Overall Mood and Behavior Item
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.
Measured: Week 12
Secondary outcomes (9)
Proportion of PGI-C Responders on the Overall Mood and Behavior Item Over Time
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.
Measured: Weeks 2, 4, 6, 8, and 12
Proportion of PGI-C Improvers on the Overall Mood and Behavior Item
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.
Measured: Weeks 2, 4, 6, 8, and 12
Mean PGI-C Overall Mood and Behavior Score
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.
Measured: Weeks 2, 4, 6, 8, and 12
Change From Baseline in Serum 25-Hydroxyvitamin D [25(OH)D] (Blood Work Subgroup)
Change from baseline in serum 25(OH)D in the optional blood work subgroup. Samples are collected at home with the Tasso Mini device.
Measured: Baseline and Week 12
Change From Baseline in Serum Vitamin B12 (Blood Work Subgroup)
Change from baseline in serum vitamin B12 in the optional blood work subgroup. Samples are collected at home with the Tasso Mini device.
Measured: Baseline and Week 12
PGI-C Overall Health and Well-being: Responder Proportion and Mean Score
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.
Measured: Weeks 2, 4, 6, 8, and 12
PGI-C Overall Nutrition: Responder Proportion and Mean Score
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.
Measured: Weeks 2, 4, 6, 8, and 12
PGI-C Mood and Behavior Domain Composite Score
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.
Measured: Weeks 2, 4, 6, 8, and 12
Change From Baseline in Emotion Dysregulation Inventory (EDI) Reactivity Score
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.
Measured: Baseline, Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion19 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group trial (1:1) with a 12-week core treatment period, followed by an optional 12-week open-label extension in which all participants, including those originally randomized to placebo, receive the active study product.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EllaOla
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863050
- Sponsor's protocol ID
- PS56
- Acronym
- BLOSSOM
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07863050
- Acronym / sponsor ID
- BLOSSOM / PS56
- Conditions
- Selective Eating, Emotional Dysregulation, Child Behavior, Healthy Children (Wellness Study)
- Keywords
- Multivitamin, Dietary Supplement, Micronutrients, Pediatric Nutrition, Mood and Behavior, Vitamin D, Vitamin B12, Decentralized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- EllaOlaIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 19 May 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group trial (1:1) with a 12-week core treatment period, followed by an optional 12-week open-label extension in which all participants, including those originally randomized to placebo, receive the active study product.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Experimental: EllaOla Kids Essentials Multivitamin | Experimental | Dietary Supplement: EllaOla Kids Essentials Unflavored Powdered MultivitaminParticipants receive EllaOla Kids Essentials Unflavored Powdered Multivitamin, administered daily at home by the parent/caregiver for 12 weeks (double-blind core period). Participants may opt into a 12-week open-label extension (Weeks 12-24) and continue receiving the active multivitamin. |
| Arm 2 - Placebo Comparator: Placebo (Tapioca Fiber) | Placebo comparator | Dietary Supplement: Placebo (Tapioca Fiber)Participants receive a matching placebo (tapioca fiber) of identical appearance, administered daily at home by the parent/caregiver for 12 weeks (double-blind core period). Participants may opt into a 12-week open-label extension (Weeks 12-24) and switch to the active multivitamin (delayed start). |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Healthy child aged 4-11 years at time of enrollment, male or female
- 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.
- 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;
- 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.
- Parent is willing and able to administer the study product daily and complete questionnaires at all timepoints
Key exclusion criteria (16 listed)
- Parent does not have a personal smartphone, internet access, or is unwilling to download Chloe.
- Child does not meet minimum threshold screening scores in two domains as specified in Inclusion Criteria 3
- Concomitant Therapies:
- Other Illnesses or Conditions:
- Known allergies or hypersensitivities to any of the study or placebo product ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EllaOla Kids Essentials Unflavored Powdered MultivitaminAlso: EllaOla Kids Essentials, Study ProductAn 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 | Arm 1 - Experimental: EllaOla Kids Essentials Multivitamin |
| Placebo (Tapioca Fiber)Also: Matching PlaceboA 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. | Dietary supplement | Arm 2 - Placebo Comparator: Placebo (Tapioca Fiber) |
Primary outcome
Proportion of PGI-C Responders on the Overall Mood and Behavior Item
Time frame: 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.
9 secondary outcomes
Proportion of PGI-C Responders on the Overall Mood and Behavior Item Over Time
Time frame: Weeks 2, 4, 6, 8, and 12
Proportion of PGI-C Improvers on the Overall Mood and Behavior Item
Time frame: Weeks 2, 4, 6, 8, and 12
Mean PGI-C Overall Mood and Behavior Score
Time frame: Weeks 2, 4, 6, 8, and 12
Change From Baseline in Serum 25-Hydroxyvitamin D [25(OH)D] (Blood Work Subgroup)
Time frame: Baseline and Week 12
Change From Baseline in Serum Vitamin B12 (Blood Work Subgroup)
Time frame: Baseline and Week 12
PGI-C Overall Health and Well-being: Responder Proportion and Mean Score
Time frame: Weeks 2, 4, 6, 8, and 12
PGI-C Overall Nutrition: Responder Proportion and Mean Score
Time frame: Weeks 2, 4, 6, 8, and 12
PGI-C Mood and Behavior Domain Composite Score
Time frame: Weeks 2, 4, 6, 8, and 12
Change From Baseline in Emotion Dysregulation Inventory (EDI) Reactivity Score
Time frame: Baseline, Weeks 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EllaOla Kids Essentials Unflavored Powdered Multivitamin in people with Selective Eating and Emotional Dysregulation, run by EllaOla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of PGI-C Responders on the Overall Mood and Behavior Item (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.