Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Suzanna L Attia

Status: Completed

Conditions: Growth Failure; Malnutrition; Wasting

Treatments: Dietary Supplement: Moringa oleifera (low dose); Dietary Supplement: Placebo; Dietary Supplement: Moringa oleifera (high dose)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04587271

K01TW009987-06 (U.S. NIH Grant/Contract)

58219

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 6 patient groups, including a placebo group

Lactating Mothers (Moringa)

Experimental group

Description:

Lactating mothers.

Treatment:

Dietary Supplement: Moringa oleifera (high dose)

Breastfeeding Infants (Moringa)

Experimental group

Description:

Breastfeeding infants from lactating mothers

Treatment:

Dietary Supplement: Moringa oleifera (high dose)

Children (Moringa)

Experimental group

Description:

Children from 6-59 months of age.

Treatment:

Dietary Supplement: Moringa oleifera (low dose)

Lactating Mothers (placebo)

Placebo Comparator group

Description:

Lactating mothers.

Treatment:

Dietary Supplement: Placebo

Breastfeeding Infants (placebo)

Placebo Comparator group

Description:

Breastfeeding infants from lactating mothers

Treatment:

Dietary Supplement: Placebo

Children (placebo)

Placebo Comparator group

Description:

Children from 6-59 months of age.

Treatment:

Dietary Supplement: Placebo