Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
2 other identifiers
interventional
100
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
July 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2022
CompletedResults Posted
Study results publicly available
November 22, 2023
CompletedNovember 22, 2023
October 1, 2023
1.1 years
October 8, 2020
July 24, 2023
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body Weight
Body weight
at baseline and 3 months
Secondary Outcomes (11)
Change in Infant Height
at baseline and 3 months
Change in Mid-Upper Arm Circumference
baseline and 3 months
Change in Vitamin A
3 months
Change in CRP Levels
baseline and 3 months
Change in the Soluble Transferrin Receptor
baseline and 3 months
- +6 more secondary outcomes
Study Arms (6)
Lactating Mothers (Moringa)
EXPERIMENTALLactating mothers.
Breastfeeding Infants (Moringa)
EXPERIMENTALBreastfeeding infants from lactating mothers
Children (Moringa)
EXPERIMENTALChildren from 6-59 months of age.
Lactating Mothers (placebo)
PLACEBO COMPARATORLactating mothers.
Breastfeeding Infants (placebo)
PLACEBO COMPARATORBreastfeeding infants from lactating mothers
Children (placebo)
PLACEBO COMPARATORChildren from 6-59 months of age.
Interventions
Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
Mothers and children will receive porridge with placebo.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kombewa County Hospital
Kisumu, 40102, Kenya
Chulaimbo Sub- County Hospital
Kisumu, 40105, Kenya
Related Publications (1)
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.
PMID: 41282517DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Suzanna Attia
- Organization
- University of Kentucky
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanna L Attia
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 8, 2020
First Posted
October 14, 2020
Study Start
July 21, 2021
Primary Completion
September 4, 2022
Study Completion
September 4, 2022
Last Updated
November 22, 2023
Results First Posted
November 22, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share