Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Malnutrition Clinical Trial

Official title:

Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587271
• Other study ID #: 58219
• Secondary ID: K01TW009987-06
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: September 4, 2022

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 4, 2022
• Est. primary completion date: September 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Failure to Thrive
• Growth Failure
• Malnutrition
• Wasting

Intervention

Dietary Supplement:
• Moringa oleifera (high dose)
Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
• Moringa oleifera (low dose)
Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
• Placebo
Mothers and children will receive porridge with placebo.

Locations

Country	Name	City	State
Kenya	Chulaimbo Sub- County Hospital	Kisumu
Kenya	Kombewa County Hospital	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
Suzanna L Attia	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Body weight	at baseline and 3 months
Secondary	Change in Infant Height	Height (body length)	at baseline and 3 months
Secondary	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	baseline and 3 months
Secondary	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..	3 months
Secondary	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.	baseline and 3 months
Secondary	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.	baseline and 3 months
Secondary	Change in Fecal Neopterin	Fecal neopterin will be measured at baseline and at 3 months.	baseline and 3 months
Secondary	Change in Fecal Myeloperoxidase	Fecal myeloperoxidase will be measured at baseline and at 3 months.	baseline and 3 months
Secondary	Change in Alpha-1-Antitrypsin	Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.	baseline and 3 months
Secondary	Change in the Prevalence of Diarrhea	Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours).	1 and 3 months
Secondary	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.	at enrollment and at 3 months
Secondary	Change in Breastmilk Vitamin A	Levels of vitamin A in breastmilk will be measured at the end of the study.	baseline and 3 months