Clinical trial · Interventional
Natural Berry Extract Treatment of Hemangiomas
NCT04020419CI-TRIAL-00070687PediaberryterminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study ending early due to program transferring to another site.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemangioma | Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PediaBerry | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pediaberry group
- description
- PediaBerry™ is a proprietary blend powdered berry extracts
- interventionNames
- Drug: PediaBerry
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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 ).
- interventionNames
- Drug: PediaBerry
Primary outcomes (1)
- measure
- Decreased Hemangioma Size
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 19 Weeks
Show eligibility criteria text
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
References
Publications (28)
- BACKGROUNDHoak 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. PMID 5105323
- BACKGROUNDGordillo 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. PMID 18817478
- BACKGROUNDGordillo 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. PMID 19817625
- BACKGROUNDGordillo 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. PMID 12125369
- BACKGROUNDGordillo 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. PMID 24497637
- BACKGROUNDGordillo 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. PMID 15163622
- BACKGROUNDBiswas 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.