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| ID | Type | Description | Link |
|---|---|---|---|
| K01TW009987-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactating Mothers (Moringa) | Experimental | Lactating mothers. |
|
| Breastfeeding Infants (Moringa) | Experimental | Breastfeeding infants from lactating mothers |
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| Children (Moringa) | Experimental | Children from 6-59 months of age. |
|
| Lactating Mothers (placebo) | Placebo Comparator | Lactating mothers. |
|
| Breastfeeding Infants (placebo) | Placebo Comparator | Breastfeeding infants from lactating mothers |
|
| Children (placebo) | Placebo Comparator | Children from 6-59 months of age. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moringa oleifera (high dose) | Dietary Supplement | Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight | at baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infant Height | Height (body length) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanna L Attia | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kombewa County Hospital | Kisumu | 40102 | Kenya | |||
| Chulaimbo Sub- County Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41282517 | Derived | Attia SL, Owuor PM, Odhiambo SA, Mogaka JN, Ondondo R, Navarro IC, Schadler A, McQuerry K, Fuchs GJ 3rd, Williams JE, Scarrow KN, McGuire MA, McGuire MK, Waterman C. Effect of Maternal Moringa oleifera Leaf Supplementation on Maternal and Infant Nutritional Status and Human Milk Output: A Pilot Single-Blinded Cluster-Randomized Trial. Curr Dev Nutr. 2025 Oct 3;9(11):107568. doi: 10.1016/j.cdnut.2025.107568. eCollection 2025 Nov. |
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After trial registration, the children's groups were removed so no children were enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactating Mothers (Moringa) | Lactating mothers. Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. |
| FG001 | Breastfeeding Infants (Moringa) | Breastfeeding infants from lactating mothers Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. |
| FG002 | Children (Moringa) | Children from 6-59 months of age. Moringa oleifera (low dose): Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months. |
| FG003 | Lactating Mothers (Placebo) | Lactating mothers. Placebo: Mothers and children will receive porridge with placebo. |
| FG004 | Breastfeeding Infants (Placebo) | Breastfeeding infants from lactating mothers Placebo: Mothers and children will receive porridge with placebo. |
| FG005 | Children (Placebo) | Children from 6-59 months of age. Placebo: Mothers and children will receive porridge with placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactating Mothers (Moringa) | Lactating mothers. Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. |
| BG001 | Breastfeeding Infants (Moringa) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Totals include combined data from mothers and infants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Body weight | Posted | Mean | Standard Deviation | g | at baseline and 3 months |
|
3 months
Diarrhea is a common occurrence in this region (Western Kenya) due to a high prevalence of parasitic, viral, and bacterial infections. Therefore diarrhea is not considered an adverse event in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactating Mothers (Moringa) | Lactating mothers. Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suzanna Attia | University of Kentucky | 859-323-6211 | suzanna.attia@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 10, 2023 | Jul 24, 2023 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D002100 | Cachexia |
| D005183 | Failure to Thrive |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
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|
| 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. |
|
| 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.. | 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. | 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. | baseline and 3 months |
| Change in Fecal Neopterin | Fecal neopterin will be measured at baseline and at 3 months. | baseline and 3 months |
| Change in Fecal Myeloperoxidase | Fecal myeloperoxidase will be measured at baseline and at 3 months. | baseline and 3 months |
| Change in Alpha-1-Antitrypsin | Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months. | baseline and 3 months |
| Change in the Prevalence of Diarrhea | Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours). | 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. | 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. | baseline and 3 months |
| Kisumu |
| 40105 |
| Kenya |
| Caregiver brought child to visits |
|
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
| BG002 | Lactating Mothers (Placebo) | Lactating mothers. Placebo: Mothers and children will receive porridge with placebo. |
| BG003 | Breastfeeding Infants (Placebo) | Breastfeeding infants from lactating mothers Placebo: Mothers and children will receive porridge with placebo. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Lactating mothers. Placebo: Mothers and children will receive porridge with placebo. |
| OG003 | Breastfeeding Infants (Placebo) | Breastfeeding infants from lactating mothers Placebo: Mothers and children will receive porridge with placebo. |
|
|
| Secondary | Change in Infant Height | Height (body length) | Height was not measured in the mothers | Posted | Mean | Standard Deviation | cm | at baseline and 3 months |
|
|
|
| Secondary | 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 | change in MUAC was not measured in the infants | Posted | Mean | Standard Deviation | cm | baseline and 3 months |
|
|
|
| Secondary | 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.. | 1 additional participant in the placebo group of mothers provided blood work (23 total as opposed to 22 from the participant flow section); Unable to get blood samples from 1 pair in the Moringa group (22 total as opposed to 23 from the participant flow section) | Posted | Mean | Standard Deviation | mcmol/L | 3 months |
|
|
|
| Secondary | 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. | 1 additional participant in the placebo group of mothers provided blood work (23 total as opposed to 22 from the participant flow section); Unable to get blood samples from 1 pair in the Moringa group (22 total as opposed to 23 from the participant flow section) | Posted | Mean | Standard Deviation | mg/L | baseline and 3 months |
|
|
|
| Secondary | 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. | 1 additional participant in the placebo group of mothers provided blood work (23 total as opposed to 22 from the participant flow section); Unable to get blood samples from 1 pair in the Moringa group (22 total as opposed to 23 from the participant flow section) | Posted | Mean | Standard Deviation | mg/L | baseline and 3 months |
|
|
|
| Secondary | Change in Fecal Neopterin | Fecal neopterin will be measured at baseline and at 3 months. | 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants. | Posted | Mean | Standard Deviation | nmol/L | baseline and 3 months |
|
|
|
| Secondary | Change in Fecal Myeloperoxidase | Fecal myeloperoxidase will be measured at baseline and at 3 months. | 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants. | Posted | Mean | Standard Deviation | ng/ML | baseline and 3 months |
|
|
|
| Secondary | Change in Alpha-1-Antitrypsin | Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months. | 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants. | Posted | Mean | Standard Deviation | mcg/L | baseline and 3 months |
|
|
|
| Secondary | Change in the Prevalence of Diarrhea | Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours). | Posted | Number | participants | 1 and 3 months |
|
|
|
| Secondary | 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. | unable to review 24-hour pumped information from 1 mother in the placebo group | Posted | Mean | Standard Deviation | mL | at enrollment and at 3 months |
|
|
|
| Secondary | Change in Breastmilk Vitamin A | Levels of vitamin A in breastmilk will be measured at the end of the study. | outcome measure data not reported because unable to perform vitamin A analysis due to funding limitations | Posted | baseline and 3 months |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Breastfeeding Infants (Moringa) | Breastfeeding infants from lactating mothers Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Lactating Mothers (Placebo) | Lactating mothers. Placebo: Mothers and children will receive porridge with placebo. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Breastfeeding Infants (Placebo) | Breastfeeding infants from lactating mothers Placebo: Mothers and children will receive porridge with placebo. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |