Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Natural Berry Extract | Recruiting, Not yet recruiting Studies | Hemangioma
Previous Study | Return to List | Next Study

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 : April 7, 2020
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gayle Gordillo, Indiana University

Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date April 7, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
Decreased Hemangioma Size [ Time Frame: 6 month treatment period ]
Decrease in the size of hemangioma > 50%
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
Hemangioma Size [ Time Frame: 6 month treatment period ]
Decrease in the size of hemangioma > 50%
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
Decreased urinary micro RNA 126 levels [ Time Frame: 6 month treatment period ]
Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
Decreased urinary miR126 levels [ Time Frame: 6 month treatment period ]
Urinary miR126 levels are analyzed using quantitative PCR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Natural Berry Extract Treatment of Hemangiomas
Official Title  ICMJE Natural Berry Extract Treatment of Hemangiomas
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE Hemangioma
Intervention  ICMJE Drug: PediaBerry
PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration
Other Name: placebo
Study Arms  ICMJE
  • Experimental: Pediaberry group
    PediaBerry™ is a proprietary blend powdered berry extracts
    Intervention: Drug: PediaBerry
  • 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 ).
    Intervention: Drug: PediaBerry
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Mohnacky, RDN (317)-278-2715 jmohnack@iu.edu
Contact: Sashwati Roy, PhD 317-278-2706 roysa@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020419
Other Study ID Numbers  ICMJE 1810087420
2R01GM095657 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gayle Gordillo, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE
  • National Institute of General Medical Sciences (NIGMS)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Gayle Gordillo, MD Indiana University
PRS Account Indiana University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP