Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Primary Purpose
Malnutrition, Wasting, Growth Failure
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Moringa oleifera (high dose)
Moringa oleifera (low dose)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Moringa oleifera, supplementation
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
Sites / Locations
- Kombewa County Hospital
- Chulaimbo Sub- County Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Lactating Mothers (Moringa)
Breastfeeding Infants (Moringa)
Children (Moringa)
Lactating Mothers (placebo)
Breastfeeding Infants (placebo)
Children (placebo)
Arm Description
Lactating mothers.
Breastfeeding infants from lactating mothers
Children from 6-59 months of age.
Lactating mothers.
Breastfeeding infants from lactating mothers
Children from 6-59 months of age.
Outcomes
Primary Outcome Measures
Change in Body Weight
Body weight
Secondary Outcome Measures
Change in Height
Height (body length)
Change in Mid-Upper Arm Circumference
Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months.
Head Circumference
Head circumference will be measured at baseline and monthly to 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..
Change in CRP Levels
C-reactive protein (CRP) will be used to measure inflammation at baseline and monthly to 3 months.
Change in the Soluble Transferrin-Ferritin Index
The soluble transferrin receptor-transferrin index (sTfR-F) will be used to evaluate anemia at baseline and monthly to 3 months.
Change in Fecal Neopterin
Fecal neopterin will be measured at baseline and monthly to 3 months.
Change in Fecal Myeloperoxidase
Fecal myeloperoxidase will be measured at baseline and monthly to 3 months.
Change in Alpha-1-Antitrypsin
Fecal alpha-1-antitrypsin will be measured at baseline and monthly to 3 months.
Prevalence of Diarrhea
Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours).
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.
Change in Breastmilk Vitamin A
Levels of vitamin A in breastmilk will be measured at the end of the study. hours.
Change in Breastmilk Retinol
Levels of retinol in breastmilk will be measured at the end of the study. hours.
Change in Breastmilk Vitamin E
Levels of vitamin E in breastmilk will be measured at the end of the study. hours.
Change in Breastmilk Catalase
Levels of catalase in breastmilk will be measured at the end of the study. hours.
Change in Breastmilk Lactoferrin
Levels of lactoferrin in breastmilk will be measured at the end of the study. hours.
Full Information
NCT ID
NCT04587271
First Posted
October 8, 2020
Last Updated
October 12, 2022
Sponsor
Suzanna L Attia
Collaborators
Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT04587271
Brief Title
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Official Title
Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
September 4, 2022 (Actual)
Study Completion Date
September 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suzanna L Attia
Collaborators
Fogarty International Center of the National Institute of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Wasting, Growth Failure
Keywords
Moringa oleifera, supplementation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactating Mothers (Moringa)
Arm Type
Experimental
Arm Description
Lactating mothers.
Arm Title
Breastfeeding Infants (Moringa)
Arm Type
Experimental
Arm Description
Breastfeeding infants from lactating mothers
Arm Title
Children (Moringa)
Arm Type
Experimental
Arm Description
Children from 6-59 months of age.
Arm Title
Lactating Mothers (placebo)
Arm Type
Placebo Comparator
Arm Description
Lactating mothers.
Arm Title
Breastfeeding Infants (placebo)
Arm Type
Placebo Comparator
Arm Description
Breastfeeding infants from lactating mothers
Arm Title
Children (placebo)
Arm Type
Placebo Comparator
Arm Description
Children from 6-59 months of age.
Intervention Type
Dietary Supplement
Intervention Name(s)
Moringa oleifera (high dose)
Intervention Description
Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Moringa oleifera (low dose)
Intervention Description
Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Mothers and children will receive porridge with placebo.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Body weight
Time Frame
18 months (monthly to 3 months plus 1 follow up)
Secondary Outcome Measure Information:
Title
Change in Height
Description
Height (body length)
Time Frame
18 months (monthly to 3 months plus 1 follow up)
Title
Change in Mid-Upper Arm Circumference
Description
Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months.
Time Frame
3 months
Title
Head Circumference
Description
Head circumference will be measured at baseline and monthly to 3 months.
Time Frame
3 months
Title
Change in Vitamin A
Description
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
Title
Change in CRP Levels
Description
C-reactive protein (CRP) will be used to measure inflammation at baseline and monthly to 3 months.
Time Frame
3 months
Title
Change in the Soluble Transferrin-Ferritin Index
Description
The soluble transferrin receptor-transferrin index (sTfR-F) will be used to evaluate anemia at baseline and monthly to 3 months.
Time Frame
3 months
Title
Change in Fecal Neopterin
Description
Fecal neopterin will be measured at baseline and monthly to 3 months.
Time Frame
3 months
Title
Change in Fecal Myeloperoxidase
Description
Fecal myeloperoxidase will be measured at baseline and monthly to 3 months.
Time Frame
3 months
Title
Change in Alpha-1-Antitrypsin
Description
Fecal alpha-1-antitrypsin will be measured at baseline and monthly to 3 months.
Time Frame
3 months
Title
Prevalence of Diarrhea
Description
Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours).
Time Frame
3 months
Title
Change in Breastmilk Volume
Description
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
1 day (at 3 months following the intervention)
Title
Change in Breastmilk Vitamin A
Description
Levels of vitamin A in breastmilk will be measured at the end of the study. hours.
Time Frame
1 day (at 3 months following the intervention)
Title
Change in Breastmilk Retinol
Description
Levels of retinol in breastmilk will be measured at the end of the study. hours.
Time Frame
1 day (at 3 months following the intervention)
Title
Change in Breastmilk Vitamin E
Description
Levels of vitamin E in breastmilk will be measured at the end of the study. hours.
Time Frame
1 day (at 3 months following the intervention)
Title
Change in Breastmilk Catalase
Description
Levels of catalase in breastmilk will be measured at the end of the study. hours.
Time Frame
1 day (at 3 months following the intervention)
Title
Change in Breastmilk Lactoferrin
Description
Levels of lactoferrin in breastmilk will be measured at the end of the study. hours.
Time Frame
1 day (at 3 months following the intervention)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanna L Attia
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kombewa County Hospital
City
Kisumu
ZIP/Postal Code
40102
Country
Kenya
Facility Name
Chulaimbo Sub- County Hospital
City
Kisumu
ZIP/Postal Code
40105
Country
Kenya
12. IPD Sharing Statement
Plan to Share IPD
No
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Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
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