Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2022-05-17
2024-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Moringa
4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days
Moringa leaf powder
capsule ingestion
Control
comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days
Placebo
capsule ingestion
Interventions
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Moringa leaf powder
capsule ingestion
Placebo
capsule ingestion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
YES:
* willing to breastfeed or pump for one week
* willing to complete study activities (at minimum measure 24 hour pumped volume at start and end of capsules, take capsules daily, and answer questions)
* has access to breastpump (in hospital and/or home)
* English speaking
* 18 years or older
* Gave birth between 2-6 weeks prior to study start
NO:
* taking metoclopramide (trade name Reglan) currently or within 2 weeks of enrollment
* taking moringa regularly or within 2 weeks of enrollment
* breast surgery (amplification, reduction, or other)
* breast condition: Insufficient Glandular tissue
* unprescribed or street drug use at any point in pregnancy, or enrolled in rehab program or receiving addiction therapy
* refuses to take 4 capsules twice daily within 2 days of study start
* wishes to withdraw within 2 days of study start
Infant
YES:
* 28-36 and 7 weeks gestation (ie 37 weeks is too old)
* 2-6 weeks old
* singleton birth
NO:
ยท any condition where breastmilk is clinically contraindicated
0 Months
ALL
Yes
Sponsors
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University of Idaho
OTHER
University of Kentucky
OTHER
Responsible Party
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Suzanna L Attia
Assistant Professor
Principal Investigators
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Suzanna Attia, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Other Identifiers
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PED-22-MORINGA
Identifier Type: -
Identifier Source: org_study_id
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