CompletedNCT04587271Updated Nov 22, 2023Results posted

Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

An interventional study of Moringa oleifera (high dose) and Moringa oleifera (low dose) in Malnutrition, Wasting and Growth Failure, sponsored by Suzanna L Attia. Completed at 2 sites in Kenya. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Suzanna L Attia · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Sex: All

Study 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.

Conditions studied

Malnutrition
Wasting
Growth Failure

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Keywords

Moringa oleifera
supplementation

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's enrollment of 100 is below the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

This is the only study on the registry with Suzanna L Attia as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 100 participants (actual)

Study arms

Experimental
Lactating Mothers (Moringa)
Lactating mothers.
Dietary Supplement: Moringa oleifera (high dose)
Experimental
Breastfeeding Infants (Moringa)
Breastfeeding infants from lactating mothers
Dietary Supplement: Moringa oleifera (high dose)
Experimental
Children (Moringa)
Children from 6-59 months of age.
Dietary Supplement: Moringa oleifera (low dose)
Placebo comparator
Lactating Mothers (placebo)
Lactating mothers.
Dietary Supplement: Placebo
Placebo comparator
Breastfeeding Infants (placebo)
Breastfeeding infants from lactating mothers
Dietary Supplement: Placebo
Placebo comparator
Children (placebo)
Children from 6-59 months of age.
Dietary Supplement: Placebo

Interventions

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

What researchers measure

Primary outcomes

Change in Body Weight
Body weight
Time frame: at baseline and 3 months

Secondary outcomes

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

Results

Posted Nov 22, 2023

Participant flow

Participant flow — Overall Study
Milestone	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Started	25	25	25	25
Completed	23	23	22	23
Not completed	2	2	3	2
Withdrew: Lost to follow-up	2	2	2	2
Withdrew: Caregiver brought child to visits	0	0	1	0

Outcome measures

PrimaryChange in Body Weight

Body weight

Time frame:: at baseline and 3 months
Reported as:: Mean · g

Change in Body Weight
g	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in Body Weight	365 ± 3102	2.5 ± 0.9	-470 ± 2988	2.5 ± 0.8

SecondaryChange in Infant Height

Height (body length)

Time frame:: at baseline and 3 months
Reported as:: Mean · cm

Change in Infant Height
cm	Breastfeeding Infants (Moringa)	Breastfeeding Infants (Placebo)
Change in Infant Height	9.1 ± 2.1	9.3 ± 1.7

SecondaryChange 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

Time frame:: baseline and 3 months
Reported as:: Mean · cm

Change in Mid-Upper Arm Circumference
cm	Lactating Mothers (Moringa)	Lactating Mothers (Placebo)
Change in Mid-Upper Arm Circumference	-1.7 ± 1.5	-1.6 ± 1.5

SecondaryChange in Vitamin A

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

Time frame:: 3 months
Reported as:: Mean · mcmol/L

Change in Vitamin A
mcmol/L	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in Vitamin A	-0.29 ± 0.50	0.08 ± 0.48	-0.23 ± 0.69	0.09 ± 0.50

SecondaryChange 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.

Time frame:: baseline and 3 months
Reported as:: Mean · mg/L

Change in CRP Levels
mg/L	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in CRP Levels	-3.5 ± 11.6	2.3 ± 6.3	-5.3 ± 8.1	8.8 ± 18.7

SecondaryChange 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.

Time frame:: baseline and 3 months
Reported as:: Mean · mg/L

Change in the Soluble Transferrin Receptor
mg/L	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in the Soluble Transferrin Receptor	-0.1 ± 2.8	2.5 ± 2.1	-1.3 ± 2.6	1.8 ± 2.7

SecondaryChange in Fecal Neopterin

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

Time frame:: baseline and 3 months
Reported as:: Mean · nmol/L

Change in Fecal Neopterin
nmol/L	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in Fecal Neopterin	21.56 ± 39.05	1076.44 ± 1387.85	26.09 ± 49.42	791.08 ± 868.18

SecondaryChange in Fecal Myeloperoxidase

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

Time frame:: baseline and 3 months
Reported as:: Mean · ng/ML

Change in Fecal Myeloperoxidase
ng/ML	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in Fecal Myeloperoxidase	35.93 ± 682.23	1071.01 ± 2687.39	105.02 ± 348.27	1225.78 ± 1276.9

SecondaryChange in Alpha-1-Antitrypsin

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

Time frame:: baseline and 3 months
Reported as:: Mean · mcg/L

Change in Alpha-1-Antitrypsin
mcg/L	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in Alpha-1-Antitrypsin	3.28 ± 25.57	-29.12 ± 195.56	0.61 ± 6.49	66.04 ± 125.94

SecondaryChange in the Prevalence of Diarrhea

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

Time frame:: 1 and 3 months
Reported as:: Number · participants

Change in the Prevalence of Diarrhea
participants	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)
Change in the Prevalence of Diarrhea	-2	1	-1	3

SecondaryChange 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.

Time frame:: at enrollment and at 3 months
Reported as:: Mean · mL

Change in Breastmilk Volume
mL	Lactating Mothers (Moringa)	Lactating Mothers (Placebo)
Change in Breastmilk Volume	435.9 ± 381.5	12.4 ± 465.7

SecondaryChange in Breastmilk Vitamin A

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

Time frame:: baseline and 3 months

No measurements were reported for this outcome.

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lactating Mothers (Moringa)	0/25 (0%)	0/25 (0%)	0/25 (0%)
Breastfeeding Infants (Moringa)	0/25 (0%)	0/25 (0%)	0/25 (0%)
Lactating Mothers (Placebo)	0/25 (0%)	0/25 (0%)	0/25 (0%)
Breastfeeding Infants (Placebo)	0/25 (0%)	0/25 (0%)	0/25 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)	Total
Mean	27.2 ± 6	0.04 ± 0.02	27.8 ± 6.2	.05 ± .02	13.8 ± 4.3

Sex: Female, Male
Sex: Female, Male(Participants)	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)	Total
Female	25	9	25	13	72
Male	0	16	0	12	28

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	25	25	25	25	100
White	0	0	0	0	0
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Lactating Mothers (Moringa)	Breastfeeding Infants (Moringa)	Lactating Mothers (Placebo)	Breastfeeding Infants (Placebo)	Total
Kenya	25	25	25	25	100

Study locations

2 sites

Kombewa County Hospital
Kisumu, 40102, Kenya
Chulaimbo Sub- County Hospital
Kisumu, 40105, Kenya

References and documents

Study documents

Protocol, analysis plan and consent form ↗ · Apr 10, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Sep 2022, 13 months.

Results were first posted in Nov 2023, 1 year 2 months after primary completion.

Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 13 months is below that.

Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 8, 2020
First posted: Oct 14, 2020
StartActual: Jul 21, 2021
Primary completionActual: Sep 4, 2022
CompletionActual: Sep 4, 2022
Results first posted: Nov 22, 2023
Last update: Nov 22, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04587271
Lead sponsor: Suzanna L Attia
Collaborators: Fogarty International Center of the National Institute of Health
Responsible party: Suzanna L Attia (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted: Oct 14, 2020
Start date: Jul 21, 2021
Primary completion: Sep 4, 2022
Completion: Sep 4, 2022
Results posted: Nov 22, 2023
Last update: Nov 22, 2023

Study contacts

Suzanna L Attia

principal investigator · University of Kentucky

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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