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Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

NCT ID: NCT04587271

Last Updated: 2023-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2022-09-04

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition Wasting Growth Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Lactating Mothers (Moringa)

Lactating mothers.

Group Type EXPERIMENTAL

Moringa oleifera (high dose)

Intervention Type DIETARY_SUPPLEMENT

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

Breastfeeding Infants (Moringa)

Breastfeeding infants from lactating mothers

Group Type EXPERIMENTAL

Moringa oleifera (high dose)

Intervention Type DIETARY_SUPPLEMENT

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

Children (Moringa)

Children from 6-59 months of age.

Group Type EXPERIMENTAL

Moringa oleifera (low dose)

Intervention Type DIETARY_SUPPLEMENT

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

Lactating Mothers (placebo)

Lactating mothers.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Mothers and children will receive porridge with placebo.

Breastfeeding Infants (placebo)

Breastfeeding infants from lactating mothers

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Mothers and children will receive porridge with placebo.

Children (placebo)

Children from 6-59 months of age.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Mothers and children will receive porridge with placebo.

Interventions

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Moringa oleifera (high dose)

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

Intervention Type DIETARY_SUPPLEMENT

Moringa oleifera (low dose)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Mothers and children will receive porridge with placebo.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Suzanna L Attia

OTHER

Sponsor Role lead

Responsible Party

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Suzanna L Attia

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Suzanna L Attia

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Kombewa County Hospital

Kisumu, , Kenya

Site Status

Chulaimbo Sub- County Hospital

Kisumu, , Kenya

Site Status

Countries

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Kenya

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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K01TW009987-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

58219

Identifier Type: -

Identifier Source: org_study_id