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N/A N=100 Randomized Single-blind Prevention

Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Malnutrition · Wasting · Growth Failure

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change in Body Weight — 365; 2.5; -470; 2.5 g

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Moringa oleifera (high dose) (Dietary_supplement); Moringa oleifera (low dose) (Dietary_supplement); Placebo (Dietary_supplement)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Suzanna L Attia
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Body Weight
365; 2.5; -470; 2.5
SECONDARY
Change in Infant Height
9.1; 9.3
SECONDARY
Change in Mid-Upper Arm Circumference
-1.7; -1.6
SECONDARY
Change in Vitamin A
-0.29; 0.08; -0.23; 0.09
SECONDARY
Change in CRP Levels
-3.5; 2.3; -5.3; 8.8
SECONDARY
Change in the Soluble Transferrin Receptor
-0.1; 2.5; -1.3; 1.8
SECONDARY
Change in Fecal Neopterin
21.56; 1076.44; 26.09; 791.08
SECONDARY
Change in Fecal Myeloperoxidase
35.93; 1071.01; 105.02; 1225.78
SECONDARY
Change in Alpha-1-Antitrypsin
3.28; -29.12; 0.61; 66.04
SECONDARY
Change in the Prevalence of Diarrhea
-2; 1; -1; 3
SECONDARY
Change in Breastmilk Volume
435.9; 12.4
SECONDARY
Change in Breastmilk Vitamin A

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04587271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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