BreastfeedingNCT05333939
Moringa Supplementation for Improved Milk Output
A study testing Moringa leaf powder in people with Breastfeeding, run by University of Kentucky at 1 site in United States.
Trial summary
The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Read more about this study
- Who is it for?
- Ages 0 months and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Moringa leaf powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 3 Aug 2024
- Phase
- Interventional
- 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 0 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Mom
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:
- any condition where breastmilk is clinically contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Moringa Oleifera Leaf Powder on Breastmilk Quantity and Quality: a Double Blinded Randomized Placebo-controlled Trial
The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Hypothesis: Four grams of moringa daily by mouth compared to placebo will increase breastmilk output and percent of mother's own milk consumed by infant.
- Conditions
- Breastfeeding
- Being tested
- Moringa leaf powder, Placebo
- Keywords
- maternal and child health
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa leaf powderDietary supplement
Also called moringa oleifera
capsule ingestion
PlaceboOther
Also called cornstarch
capsule ingestion
| Study group | Role | What they receive |
|---|---|---|
| Moringa | Experimental | 4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days Receives: Dietary Supplement: Moringa leaf powder |
| Control | Placebo comparator | comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milk output
24 hour milk output at 7 days
Measured: 7 days
Secondary outcomes (1)
% mother's own milk consumed by infant
% of mother's own milk (over total enteral nutrition) consumed by infant at 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start17 May 2022
- Primary completion3 Aug 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo controlled randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- University of Idaho
- Responsible party
- Principal investigator, Suzanna L Attia, University of Kentucky
- Investigators
- Suzanna Attia, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333939
- Sponsor's protocol ID
- PED-22-MORINGA
- Status last verified
- Oct 2024
- First submitted
- 28 Mar 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Moringa Oleifera Leaf Powder on Breastmilk Quantity and Quality: a Double Blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05333939
- Acronym / sponsor ID
- PED-22-MORINGA
- Conditions
- Breastfeeding
- Keywords
- maternal and child health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- University of Idaho
- Study start
- 17 May 2022 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Hypothesis: Four grams of moringa daily by mouth compared to placebo will increase breastmilk output and percent of mother's own milk consumed by infant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo controlled randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Moringa | Experimental | Dietary Supplement: Moringa leaf powder4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days |
| Control | Placebo comparator | Other: Placebocomparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa leaf powderAlso: moringa oleiferacapsule ingestion | Dietary supplement | Moringa |
| PlaceboAlso: cornstarchcapsule ingestion | Other | Control |
Primary outcome
Milk output
Time frame: 7 days
24 hour milk output at 7 days
1 secondary outcome
% mother's own milk consumed by infant
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanna Attia, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa leaf powder in people with Breastfeeding, run by University of Kentucky at 1 site 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?
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: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Milk output (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2024.