Natural Berry Extract Treatment of Hemangiomas (Pediaberry)

October 18, 2023 updated by: Gayle Gordillo
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Hemangioma Size
Time Frame: 6 month treatment period
Decrease in the size of hemangioma > 50%
6 month treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased urinary micro RNA 126 levels
Time Frame: 6 month treatment period
Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions
6 month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gayle Gordillo

Collaborators

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

Investigators

  • Principal Investigator: Gayle Gordillo, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1810087420
  • 2R01GM095657 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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