Clinical trial NCT04587271: Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Official title: Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Wasting
Growth Failure
Keywords: Moringa oleifera
supplementation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2020-10-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: at baseline and 3 months
Secondary outcomes:
measure: Change in Infant Height
timeFrame: at baseline and 3 months
measure: Change in Mid-Upper Arm Circumference
timeFrame: baseline and 3 months
measure: Change in Vitamin A
timeFrame: 3 months
measure: Change in CRP Levels
timeFrame: baseline and 3 months
measure: Change in the Soluble Transferrin Receptor
timeFrame: baseline and 3 months
measure: Change in Fecal Neopterin
timeFrame: baseline and 3 months
measure: Change in Fecal Myeloperoxidase
timeFrame: baseline and 3 months
measure: Change in Alpha-1-Antitrypsin
timeFrame: baseline and 3 months
measure: Change in the Prevalence of Diarrhea
timeFrame: 1 and 3 months
measure: Change in Breastmilk Volume
timeFrame: at enrollment and at 3 months
measure: Change in Breastmilk Vitamin A
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kombewa County Hospital
city: Kisumu
country: Kenya
facility: Chulaimbo Sub- County Hospital
Study officials:
affiliation: University of Kentucky
name: Suzanna L Attia
role: PRINCIPAL_INVESTIGATOR
References: