[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659290":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":58,"interventions":71,"overallOfficials":44,"centralContacts":44,"locations":44,"responsibleParty":86,"collaborators":88,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":44,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":125,"whyStopped":44,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":44},{"fullName":5,"class":6},"EllaOla","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of PGI-C Responders on the Overall Mood and Behavior Item","Proportion of participants rated by their parent\u002Fcaregiver 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.","Week 12",[14,18,21,24,28,31,34,37,40],{"measure":15,"description":16,"timeFrame":17},"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.","Weeks 2, 4, 6, 8, and 12",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":26,"timeFrame":27},"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.","Baseline and Week 12",{"measure":29,"description":30,"timeFrame":27},"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.",{"measure":32,"description":33,"timeFrame":17},"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.",{"measure":35,"description":36,"timeFrame":17},"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.",{"measure":38,"description":39,"timeFrame":17},"PGI-C Mood and Behavior Domain Composite Score","Mean of the two PGI-C Mood and Behavior domain items (tantrums\u002Fmeltdowns 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.",{"measure":41,"description":42,"timeFrame":43},"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.","Baseline, Weeks 4, 8, and 12",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",{"masking":51,"maskingDescription":52,"whoMasked":53},"QUADRUPLE","This is a double-blind study. Participants, parents\u002Fcaregivers, investigators, study staff involved in data collection and outcome assessment, and the Sponsor are blinded to treatment assignment. The active product and placebo have identical packaging, labeling, and appearance. The randomization sequence is generated within the Chloe platform, and staff involved in data collection or outcome assessment do not have access to it. Unblinding will occur only after study completion and database lock, or in a participant safety emergency that requires knowledge of treatment assignment; any emergency unblinding will be documented. During the optional open-label extension (Weeks 12-24), all participants receive the active product. Each participant's original core-period assignment stays masked from participants, caregivers, and outcome assessors until the core-period database is locked.",[54,55,56,57],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Arm 1 - Experimental: EllaOla Kids Essentials Multivitamin","EXPERIMENTAL","Participants receive EllaOla Kids Essentials Unflavored Powdered Multivitamin, administered daily at home by the parent\u002Fcaregiver 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.",[64],"Dietary Supplement: EllaOla Kids Essentials Unflavored Powdered Multivitamin",{"label":66,"type":67,"description":68,"interventionNames":69},"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\u002Fcaregiver 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).",[70],"Dietary Supplement: Placebo (Tapioca Fiber)",[72,80],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"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\u002Fcaregivers 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.",[60],[78,79],"EllaOla Kids Essentials","Study Product",{"type":73,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Placebo (Tapioca Fiber)","A tapioca fiber powder with no vitamins or minerals, matched to the study product in appearance, packaging, and labeling. Parents\u002Fcaregivers 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.",[66],[85],"Matching Placebo",{"type":87,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[89],{"name":90,"class":6},"People Science, Inc.","100659290","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-100659290",false,"NCT07863050","Unflavored Powdered Multivitamin in Children","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","BLOSSOM","Inclusion Criteria:\n\n1. Healthy child aged 4-11 years at time of enrollment, male or female\n2. 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.\n3. Parent reports active concern\u002Fchallenge in behavior and selective eating confirmed by minimum threshold scores on three screening instruments: a. Selective Eating: \\\u003C\u002F= 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;\n4. 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.\n5. Parent is willing and able to administer the study product daily and complete questionnaires at all timepoints\n6. Willing and able to maintain current diet, physical activity consistently throughout the study duration.\n7. Parent is able to read and understand English.\n8. Parent is able to read, understand, and provide informed consent.\n9. Parent is able to use a personal smartphone device and download Chloe by People Science.\n10. Able to receive shipment of the product at an address within the United States.\n11. Parent is able to complete study assessments over the course of up to 20 weeks.\n\nExclusion Criteria:\n\nAny potential participants who:\n\n1. Parent does not have a personal smartphone, internet access, or is unwilling to download Chloe.\n2. Child does not meet minimum threshold screening scores in two domains as specified in Inclusion Criteria 3\n3. Concomitant Therapies:\n\n   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).\n   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\n   3. Participants receiving any investigational therapies or treatments within 30 days prior to randomization.\n   4. Caregiver intends to introduce any new medications, supplements, or herbal remedies targeting behavior or appetite during the study period.\n4. Other Illnesses or Conditions:\n\n   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\n   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.\n   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.\n5. Known allergies or hypersensitivities to any of the study or placebo product ingredients\n6. 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\n\n   a. Only one child per household may enroll in this research at a time\n7. 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",true,"ALL","4 Years","11 Years",{"count":104,"type":105},166,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.\n\nThe main questions it aims to answer are:\n\nDo 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?\n\nResearchers 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.\n\nParticipants will:\n\nBe randomly assigned to receive either the multivitamin or the placebo. Neither the families nor the study team will know which one the child gets.\n\nHave a parent or caregiver mix the powder into the child's food or drink once a day at home for 12 weeks.\n\nHave 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.\n\nChoose whether to do an optional at-home blood collection at the start and at Week 12.\n\nChoose 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.",[111,112,113,114],"Selective Eating","Emotional Dysregulation","Child Behavior","Healthy Children (Wellness Study)",[116,117,118,119,120,121,122,123,124],"Multivitamin","Dietary Supplement","Micronutrients","Pediatric Nutrition","Mood and Behavior","Vitamin D","Vitamin B12","Decentralized Clinical Trial","Placebo Controlled","NOT_YET_RECRUITING","2026-10-07",{"date":128,"type":129},"2026-10-13","ACTUAL",{"date":131,"type":105},"2026-10-14",{"date":133,"type":105},"2027-05-19",{"name":5,"class":6}]