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HemangiomaEarly Phase 1PediaberryNCT04020419

Natural Berry Extract Treatment of Hemangiomas

A Early Phase 1 study testing PediaBerry in people with Hemangioma, run by Gayle Gordillo at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 19 weeks
Conditions the study is for
Hemangioma
What is being tested?
PediaBerry
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
2 sitesUnited States
Study dates
1 Dec 2020to 24 May 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 19 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age
  • Hemangioma size ≥ 1 cm diameter

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.

Read the 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.

Conditions
Hemangioma
Being tested
PediaBerry
Keywords
miR126, Pediaberry
Medical subject headings
Hemangioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PediaBerryDrug

    Also called placebo

    PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration

Study groups in NCT04020419
Study groupRoleWhat they receive
Pediaberry groupExperimentalPediaBerry™ is a proprietary blend powdered berry extracts
Receives: Drug: PediaBerry
PlaceboPlacebo comparatorPlacebo: 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 ).
Receives: Drug: PediaBerry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decreased Hemangioma Size

    Decrease in the size of hemangioma > 50%

    Measured: 6 month treatment period

Secondary outcomes (1)

  1. Decreased urinary micro RNA 126 levels

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

    Measured: 6 month treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start1 Dec 2020
  3. Primary completion24 May 2023
  4. Study completion24 May 2023

Why it stopped: Study ending early due to program transferring to another site.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
pilot study to determine effect size for possible FDA phase I/II trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020419
Sponsor's protocol ID
1810087420
Other IDs
2R01GM095657
Acronym
Pediaberry
Status last verified
Oct 2023
First submitted
24 Jun 2019
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hoak JC, Warner ED, Cheng HF, Fry GL, Hankenson RR. Hemangioma with thrombocytopenia and microangiopathic anemia (Kasabach-Merritt syndrome): an animal model. J Lab Clin Med. 1971 Jun;77(6):941-50. No abstract available.

    PubMed 5105323

  • Gordillo G, Fang H, Khanna S, Harper J, Phillips G, Sen CK. Oral administration of blueberry inhibits angiogenic tumor growth and enhances survival of mice with endothelial cell neoplasm. Antioxid Redox Signal. 2009 Jan;11(1):47-58. doi: 10.1089/ars.2008.2150.

    PubMed 18817478

  • Gordillo G, Fang H, Park H, Roy S. Nox-4-dependent nuclear H2O2 drives DNA oxidation resulting in 8-OHdG as urinary biomarker and hemangioendothelioma formation. Antioxid Redox Signal. 2010 Apr 15;12(8):933-43. doi: 10.1089/ars.2009.2917.

    PubMed 19817625

  • Gordillo GM, Atalay M, Roy S, Sen CK. Hemangioma model for in vivo angiogenesis: inducible oxidative stress and MCP-1 expression in EOMA cells. Methods Enzymol. 2002;352:422-32. doi: 10.1016/s0076-6879(02)52038-3. No abstract available.

    PubMed 12125369

  • Gordillo GM, Biswas A, Khanna S, Pan X, Sinha M, Roy S, Sen CK. Dicer knockdown inhibits endothelial cell tumor growth via microRNA 21a-3p targeting of Nox-4. J Biol Chem. 2014 Mar 28;289(13):9027-38. doi: 10.1074/jbc.M113.519264. Epub 2014 Feb 4.

    PubMed 24497637

  • Gordillo GM, Onat D, Stockinger M, Roy S, Atalay M, Beck FM, Sen CK. A key angiogenic role of monocyte chemoattractant protein-1 in hemangioendothelioma proliferation. Am J Physiol Cell Physiol. 2004 Oct;287(4):C866-73. doi: 10.1152/ajpcell.00238.2003. Epub 2004 May 26.

    PubMed 15163622

  • Biswas A, Khanna S, Roy S, Pan X, Sen CK, Gordillo GM. Endothelial cell tumor growth is Ape/ref-1 dependent. Am J Physiol Cell Physiol. 2015 Sep 1;309(5):C296-307. doi: 10.1152/ajpcell.00022.2015. Epub 2015 Jun 24.

    PubMed 26108661

  • Biswas A, Pan X, Meyer M, Khanna S, Roy S, Pearson G, Kirschner R, Witman P, Faith EF, Sen CK, Gordillo GM. Urinary Excretion of MicroRNA-126 Is a Biomarker for Hemangioma Proliferation. Plast Reconstr Surg. 2017 Jun;139(6):1277e-1284e. doi: 10.1097/PRS.0000000000003349.

    PubMed 28538565

  • Atalay M, Gordillo G, Roy S, Rovin B, Bagchi D, Bagchi M, Sen CK. Anti-angiogenic property of edible berry in a model of hemangioma. FEBS Lett. 2003 Jun 5;544(1-3):252-7. doi: 10.1016/s0014-5793(03)00509-x.

    PubMed 12782326

  • Biswas A, Clark EC, Sen CK, Gordillo GM. Phytochemical Inhibition of Multidrug Resistance Protein-1 as a Therapeutic Strategy for Hemangioendothelioma. Antioxid Redox Signal. 2017 Jun 10;26(17):1009-1019. doi: 10.1089/ars.2016.6881. Epub 2016 Nov 9.

    PubMed 27706944

  • Gordillo GM, Biswas A, Khanna S, Spieldenner JM, Pan X, Sen CK. Multidrug Resistance-associated Protein-1 (MRP-1)-dependent Glutathione Disulfide (GSSG) Efflux as a Critical Survival Factor for Oxidant-enriched Tumorigenic Endothelial Cells. J Biol Chem. 2016 May 6;291(19):10089-103. doi: 10.1074/jbc.M115.688879. Epub 2016 Mar 9.

    PubMed 26961872

  • Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. doi: 10.1067/mjd.2003.200.

    PubMed 12664009

  • Dinehart SM, Kincannon J, Geronemus R. Hemangiomas: evaluation and treatment. Dermatol Surg. 2001 May;27(5):475-85. doi: 10.1046/j.1524-4725.2001.00227.x.

    PubMed 11359498

  • Drolet BA, Esterly NB, Frieden IJ. Hemangiomas in children. N Engl J Med. 1999 Jul 15;341(3):173-81. doi: 10.1056/NEJM199907153410307. No abstract available.

    PubMed 10403856

  • Metry DW, Hebert AA. Benign cutaneous vascular tumors of infancy: when to worry, what to do. Arch Dermatol. 2000 Jul;136(7):905-14. doi: 10.1001/archderm.136.7.905.

    PubMed 10890993

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PediaBerry in people with Hemangioma, run by Gayle Gordillo at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study ending early due to program transferring to another site.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreased Hemangioma Size (time frame: 6 month treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04020419, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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