Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Not Applicable

Completed

Conditions: Malnutrition
Wasting
Growth Failure

Interventions: Dietary Supplement: Moringa oleifera (high dose)
Dietary Supplement: Placebo
Dietary Supplement: Moringa oleifera (low dose)

Registration Number: NCT04587271

Lead Sponsor: Suzanna L Attia

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breastfeeding Infants (Moringa)	Moringa oleifera (high dose)	Breastfeeding infants from lactating mothers
Lactating Mothers (placebo)	Placebo	Lactating mothers.
Lactating Mothers (Moringa)	Moringa oleifera (high dose)	Lactating mothers.
Children (Moringa)	Moringa oleifera (low dose)	Children from 6-59 months of age.
Breastfeeding Infants (placebo)	Placebo	Breastfeeding infants from lactating mothers
Children (placebo)	Placebo	Children from 6-59 months of age.

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	at baseline and 3 months	Body weight

Secondary Outcome Measures

Name	Time	Method
Change in CRP Levels	baseline and 3 months	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.
Change in the Soluble Transferrin Receptor	baseline and 3 months	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.
Change in Mid-Upper Arm Circumference	baseline and 3 months	Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported
Change in Alpha-1-Antitrypsin	baseline and 3 months	Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.
Change in Breastmilk Volume	at enrollment and at 3 months	Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours.
Change in Fecal Neopterin	baseline and 3 months	Fecal neopterin will be measured at baseline and at 3 months.
Change in the Prevalence of Diarrhea	1 and 3 months	Proportion of participants experiencing diarrhea (\> 3 watery stools in 24 hours).
Change in Fecal Myeloperoxidase	baseline and 3 months	Fecal myeloperoxidase will be measured at baseline and at 3 months.
Change in Breastmilk Vitamin A	baseline and 3 months	Levels of vitamin A in breastmilk will be measured at the end of the study.
Change in Infant Height	at baseline and 3 months	Height (body length)
Change in Vitamin A	3 months	Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..