MalnutritionNCT04587271
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
A study testing Moringa oleifera (high dose) and Moringa oleifera (low dose) in people with Malnutrition and Wasting, run by Suzanna L Attia at 2 sites in Kenya.
Trial summary
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Wasting, Growth Failure
- What is being tested?
- Moringa oleifera (high dose) and Moringa oleifera (low dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesKenya
- Study dates
- 21 Jul 2021to 4 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- lactating women at least 18 years of age and their exclusively breastfed infants within 14 days of delivery.
- children 6-59 months of age who eat food
Who cannot join
- regular maternal consumption of moringa
- receipt and consumption of food supplementation program
- inability to feed orally or refusal to eat moringa or placebo porridge
- for infants, prematurity (<36 weeks gestational age)
- for infants, significant congenital disease
- for infants, inability to feed orally
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Kombewa County Hospital
Kisumu, 40102
Chulaimbo Sub- County Hospital
Kisumu, 40105
About this study
Official title: Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected.
Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.
- Conditions
- Malnutrition, Wasting, Growth Failure
- Being tested
- Moringa oleifera (high dose), Moringa oleifera (low dose), Placebo
- Keywords
- Moringa oleifera, supplementation
- Medical subject headings
- Malnutrition, Cachexia, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera (high dose)Dietary supplement
Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
Moringa oleifera (low dose)Dietary supplement
Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
PlaceboDietary supplement
Mothers and children will receive porridge with placebo.
| Study group | Role | What they receive |
|---|---|---|
| Lactating Mothers (Moringa) | Experimental | Lactating mothers. Receives: Dietary Supplement: Moringa oleifera (high dose) |
| Breastfeeding Infants (Moringa) | Experimental | Breastfeeding infants from lactating mothers Receives: Dietary Supplement: Moringa oleifera (high dose) |
| Children (Moringa) | Experimental | Children from 6-59 months of age. Receives: Dietary Supplement: Moringa oleifera (low dose) |
| Lactating Mothers (placebo) | Placebo comparator | Lactating mothers. Receives: Dietary Supplement: Placebo |
| Breastfeeding Infants (placebo) | Placebo comparator | Breastfeeding infants from lactating mothers Receives: Dietary Supplement: Placebo |
| Children (placebo) | Placebo comparator | Children from 6-59 months of age. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Body weight
Measured: at baseline and 3 months
Secondary outcomes (11)
Change in Infant Height
Height (body length)
Measured: at baseline and 3 months
Change in Mid-Upper Arm Circumference
Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported
Measured: baseline and 3 months
Change in Vitamin A
Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..
Measured: 3 months
Change in CRP Levels
C-reactive protein (CRP) will be used to measure inflammation at baseline and monthly to 3 months. Change from baseline to 3 months reported. Negative values are considered a better outcome.
Measured: baseline and 3 months
Change in the Soluble Transferrin Receptor
The soluble transferrin receptor (sTFR) will be used to evaluate anemia at baseline and monthly to 3 months. Change from baseline to 3 months reported.
Measured: baseline and 3 months
Change in Fecal Neopterin
Fecal neopterin will be measured at baseline and at 3 months.
Measured: baseline and 3 months
Change in Fecal Myeloperoxidase
Fecal myeloperoxidase will be measured at baseline and at 3 months.
Measured: baseline and 3 months
Change in Alpha-1-Antitrypsin
Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.
Measured: baseline and 3 months
Change in the Prevalence of Diarrhea
Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours).
Measured: 1 and 3 months
Change in Breastmilk Volume
Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours.
Measured: at enrollment and at 3 months
Change in Breastmilk Vitamin A
Levels of vitamin A in breastmilk will be measured at the end of the study.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start21 Jul 2021
- Primary completion4 Sep 2022
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzanna L Attia
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor-investigator, Suzanna L Attia, University of Kentucky
- Investigators
- Suzanna L Attia, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587271
- Sponsor's protocol ID
- 58219
- Other IDs
- K01TW009987-06
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2020
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Attia SL, Owuor PM, Odhiambo SA, Mogaka JN, Ondondo R, Navarro IC, Schadler A, McQuerry K, Fuchs GJ 3rd, Williams JE, Scarrow KN, McGuire MA, McGuire MK, Waterman C. Effect of Maternal Moringa oleifera Leaf Supplementation on Maternal and Infant Nutritional Status and Human Milk Output: A Pilot Single-Blinded Cluster-Randomized Trial. Curr Dev Nutr. 2025 Oct 3;9(11):107568. doi: 10.1016/j.cdnut.2025.107568. eCollection 2025 Nov.
PubMed 41282517
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
- ClinicalTrials.gov ID
- NCT04587271
- Acronym / sponsor ID
- 58219
- Conditions
- Malnutrition, Wasting, Growth Failure
- Keywords
- Moringa oleifera, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Suzanna L AttiaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected.
Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lactating Mothers (Moringa) | Experimental | Dietary Supplement: Moringa oleifera (high dose)Lactating mothers. |
| Breastfeeding Infants (Moringa) | Experimental | Dietary Supplement: Moringa oleifera (high dose)Breastfeeding infants from lactating mothers |
| Children (Moringa) | Experimental | Dietary Supplement: Moringa oleifera (low dose)Children from 6-59 months of age. |
| Lactating Mothers (placebo) | Placebo comparator | Dietary Supplement: PlaceboLactating mothers. |
| Breastfeeding Infants (placebo) | Placebo comparator | Dietary Supplement: PlaceboBreastfeeding infants from lactating mothers |
| Children (placebo) | Placebo comparator | Dietary Supplement: PlaceboChildren from 6-59 months of age. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- lactating women at least 18 years of age and their exclusively breastfed infants within 14 days of delivery.
- children 6-59 months of age who eat food
Key exclusion criteria (6 listed)
- regular maternal consumption of moringa
- receipt and consumption of food supplementation program
- inability to feed orally or refusal to eat moringa or placebo porridge
- for infants, prematurity (<36 weeks gestational age)
- for infants, significant congenital disease
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 oleifera (high dose)Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. | Dietary supplement | Breastfeeding Infants (Moringa), Lactating Mothers (Moringa) |
| Moringa oleifera (low dose)Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months. | Dietary supplement | Children (Moringa) |
| PlaceboMothers and children will receive porridge with placebo. | Dietary supplement | Breastfeeding Infants (placebo), Children (placebo), Lactating Mothers (placebo) |
Primary outcome
Change in Body Weight
Time frame: at baseline and 3 months
Body weight
11 secondary outcomes
Change in Infant Height
Time frame: at baseline and 3 months
Change in Mid-Upper Arm Circumference
Time frame: baseline and 3 months
Change in Vitamin A
Time frame: 3 months
Change in CRP Levels
Time frame: baseline and 3 months
Change in the Soluble Transferrin Receptor
Time frame: baseline and 3 months
Change in Fecal Neopterin
Time frame: baseline and 3 months
Change in Fecal Myeloperoxidase
Time frame: baseline and 3 months
Change in Alpha-1-Antitrypsin
Time frame: baseline and 3 months
Change in the Prevalence of Diarrhea
Time frame: 1 and 3 months
Change in Breastmilk Volume
Time frame: at enrollment and at 3 months
Change in Breastmilk Vitamin A
Time frame: baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41282517Attia SL, Owuor PM, Odhiambo SA, Mogaka JN, Ondondo R, Navarro IC, Schadler A, McQuerry K, Fuchs GJ 3rd, Williams JE, Scarrow KN, McGuire MA, McGuire MK, Waterman C. Effect of Maternal Moringa oleifera Leaf Supplementation on Maternal and Infant Nutritional Status and Human Milk Output: A Pilot Single-Blinded Cluster-Randomized Trial. Curr Dev Nutr. 2025 Oct 3;9(11):107568. doi: 10.1016/j.cdnut.2025.107568. eCollection 2025 Nov.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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 L Attia principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa oleifera (high dose) and Moringa oleifera (low dose) in people with Malnutrition and Wasting, run by Suzanna L Attia at 2 sites in Kenya.
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 6 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: finished, as of the sponsor's last update on 22 Nov 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Body Weight (time frame: at baseline and 3 months). 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 NCT04587271, which also lists 1 linked publication.
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 22 Nov 2023.