Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Natural Berry Extract Treatment of Hemangiomas (Pediaberry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020419
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gayle Gordillo, Indiana University

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
Hemangioma Drug: PediaBerry 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 in the at Riley 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: pilot 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: Other
Official Title: Natural Berry Extract Treatment of Hemangiomas
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

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 Name: 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 Name: placebo




Primary Outcome Measures :
  1. Decreased Hemangioma Size [ Time Frame: 6 month treatment period ]
    Decrease in the size of hemangioma > 50%


Secondary Outcome Measures :
  1. Decreased urinary micro RNA 126 levels [ Time Frame: 6 month treatment period ]
    Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with hemangiomas ≤ 4 months of corrected gestational age
  • Hemangioma size ≥ 1.5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020419


Contacts
Layout table for location contacts
Contact: Jennifer Mohnacky, RDN (317)-278-2715 jmohnack@iu.edu
Contact: Sashwati Roy, PhD 317-278-2706 roysa@iu.edu

Locations
Layout table for location information
United States, Indiana
Riley Hospital for Children Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Mohnacky, RDN    317-278-2715    jmohnack@iu.edu   
Contact: Tammy Garrett, RN    (317) 278-0290    tjgarret@iupui.edu   
Principal Investigator: Gayle Gordillo, MD         
Sponsors and Collaborators
Indiana University
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Gayle Gordillo, MD Indiana University

Publications:

Layout table for additonal information
Responsible Party: Gayle Gordillo, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT04020419     History of Changes
Other Study ID Numbers: 1810087420
2R01GM095657 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gayle Gordillo, Indiana University:
miR126
Pediaberry
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms