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Pediaberry: Natural Berry Extract Treatment of Hemangiomas

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04020419
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH), National Institutes of Health (NIH) (NIH)
66
Enrollment
2
Locations
2
Arms
25
Anticipated Duration (Months)
33
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. Subjects will be followed to age 18 months. A total of 44 subjects will be PediaBerry group and 22 subjects in the placebo control group.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

PediaBerry™ is a proprietary blend of powdered berry extracts. Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from -nature-assorted-food-color ).

Cream vehicle is mixed with PediaBerry™ or placebo at the time of application.Children will receive once daily topical and oral gavage dosing of PediaBerry or placebo.

The first study visit will take place within 2 weeks of subject recruitment. The subject enrollment, consenting and randomization will occur as study visit #0 and will occur at Riley Children's Hospital or Nationwide Children's Hospital. Data collection will be the same at all study visits starting with study visit #1 until the completion of the study. The first dose of PediaBerry™ or placebo will be administered prior to completion of study visit #1, and will also be given at study visits #2-6. Study visits #2-6 will occur monthly study visits until the subject completes 6 months of treatment.Subjects will be weighed and treatment doses adjusted accordingly. Study visits #7-11 to watch for signs of rebound hemangioma proliferation will occur every other month until age 12 months and then at age 15 and 18 months. Urine samples, photos and caliper measurements will occur at each study visit. Some subjects may have less than 11 study visits depending on the age at the time of subject enrollment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
pilot study to determine effect size for possible FDA phase I/II trialpilot study to determine effect size for possible FDA phase I/II trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
investigational pharmacy will have access to randomization schemes and will package study drug from bulk supplies. All other study team members and participants are blinded.
Primary Purpose:
Treatment
Official Title:
Natural Berry Extract Treatment of Hemangiomas
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pediaberry group

PediaBerry™ is a proprietary blend powdered berry extracts

Drug: PediaBerry
PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration
Other Names:
  • placebo

    		•
    Placebo Comparator: Placebo

    Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ).

    Drug: PediaBerry
    PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decreased Hemangioma Size [6 month treatment period]

      Decrease in the size of hemangioma > 50%

    Secondary Outcome Measures

    1. Decreased urinary micro RNA 126 levels [6 month treatment period]

      Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 19 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age

    • Hemangioma size ≥ 1 cm diameter

    Exclusion Criteria:

    • Children with hemangiomas that threaten the life of the child or development of vital structures.

    • Children who are breast feeding and mother is taking beta blocker medication

    • Children with previously treated hemangiomas

    • Congenital hemangiomas - cannot distinguish between rapidly involuting and non-involuting congenital hemangiomas

    • Hemangiomas located in the perineal/diapering area - product will get contaminated or wiped off with diapering

    • Children with food allergies to blueberries or any other kind of berry

    • Legal guardian unable to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riley Hospital for Children Indianapolis Indiana United States 46202
    2 Nationwide Children's Hospital Columbus Ohio United States 43205

    Sponsors and Collaborators

    • Indiana University
    • National Institute of General Medical Sciences (NIGMS)
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Gayle Gordillo, MD, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gayle Gordillo, Professor, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04020419
    Other Study ID Numbers:
    • 1810087420
    • 2R01GM095657
    First Posted:
    Jul 16, 2019
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gayle Gordillo, Professor, Indiana University
    miR126
    Pediaberry
    Additional relevant MeSH terms:
    Hemangioma

    Study Results

    No Results Posted as of Aug 16, 2021