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出境医 / 临床实验 / Natural Berry Extract Treatment of Hemangiomas (Pediaberry)
Natural Berry Extract Treatment of Hemangiomas (Pediaberry)
Study Description
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 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 Design
| 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: | Treatment |
| Official Title: | Natural Berry Extract Treatment of Hemangiomas |
| Actual Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- Decreased Hemangioma Size [ Time Frame: 6 month treatment period ]Decrease in the size of hemangioma > 50%
Secondary Outcome Measures :
- Decreased urinary micro RNA 126 levels [ Time Frame: 6 month treatment period ]Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions
Eligibility Criteria
| Ages Eligible for Study: | 1 Month to 4 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Amy O Miller, MA/CCRP | (317)-278-2720 | amym@iu.edu | |
| Contact: Sashwati Roy, PhD | 317-278-2706 | roysa@iu.edu |
Locations
| United States, Indiana | |
| Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Amy O Miller, MA/CCRP 317-278-2720 amym@iu.edu | |
| Contact: Ashley Moore, RN (317) 278-7858 amurdick@iu.edu | |
| Principal Investigator: Gayle Gordillo, MD | |
Sponsors and Collaborators
Indiana University
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Gayle Gordillo, MD | Indiana University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 24, 2019 | ||||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||||
| Last Update Posted Date | February 9, 2021 | ||||||||
| Actual Study Start Date ICMJE | December 1, 2020 | ||||||||
| Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Decreased Hemangioma Size [ Time Frame: 6 month treatment period ] Decrease in the size of hemangioma > 50%
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| Original Primary Outcome Measures ICMJE |
Hemangioma Size [ Time Frame: 6 month treatment period ] Decrease in the size of hemangioma > 50%
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Decreased urinary micro RNA 126 levels [ Time Frame: 6 month treatment period ] Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions
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| Original Secondary Outcome Measures ICMJE |
Decreased urinary miR126 levels [ Time Frame: 6 month treatment period ] Urinary miR126 levels are analyzed using quantitative PCR
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| 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 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. |
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| 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: Treatment
|
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| 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
|
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
66 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2022 | ||||||||
| Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 1 Month to 4 Months (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Gayle Gordillo, Indiana University | ||||||||
| Study Sponsor ICMJE | Indiana University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Indiana University | ||||||||
| Verification Date | February 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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