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Completed

NCT Number: NCT04587271

Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulaimbo Sub- County Hospital, Kisumu, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moringa oleifera (high dose)

Dietary Supplement

Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.

Moringa oleifera (low dose)

Dietary Supplement

Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.

Placebo

Dietary Supplement

Mothers and children will receive porridge with placebo.

Primary outcomes

  1. Change in Body Weight

    Time frame: at baseline and 3 months

    Body weight

Secondary outcomes

  1. Change in Infant Height

    Time frame: at baseline and 3 months

    Height (body length)

  2. Change in Mid-Upper Arm Circumference

    Time frame: 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

  3. Change in Vitamin A

    Time frame: 3 months

    Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..

  4. Change in CRP Levels

    Time frame: 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.

  5. Change in the Soluble Transferrin Receptor

    Time frame: 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.

  6. Change in Fecal Neopterin

    Time frame: baseline and 3 months

    Fecal neopterin will be measured at baseline and at 3 months.

  7. Change in Fecal Myeloperoxidase

    Time frame: baseline and 3 months

    Fecal myeloperoxidase will be measured at baseline and at 3 months.

  8. Change in Alpha-1-Antitrypsin

    Time frame: baseline and 3 months

    Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.

  9. Change in the Prevalence of Diarrhea

    Time frame: 1 and 3 months

    Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours).

  10. Change in Breastmilk Volume

    Time frame: 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.

  11. Change in Breastmilk Vitamin A

    Time frame: baseline and 3 months

    Levels of vitamin A in breastmilk will be measured at the end of the study.

Sponsors and collaborators

Lead sponsor

Suzanna L Attia

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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