NCT04574544

Brief Summary

Malnutrition among children, especially stunting is a public health problem in Cameroon. This study assesses the impact of zinc supplementation of children and nutrition education of mothers on the nutritional status of the children in the rural community. Dietary surveys, nutritional status, zinc supplementation of children and nutrition education of mothers were carried out. After nutrition education and zinc supplementation, the study showed positive impact of both intervention on the nutritional status of children.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2015

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

September 15, 2020

Last Update Submit

October 2, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Zinc supplementation among children in the rural community

    The supplemented children received the oral zinc sulphate per day for two week and serum zinc concentration were taken before and after the intervention.

    Zinc supplementation: 14 days

  • Nutrition education of mothers and improvement of nutritionnal status of children

    The appropriate information of child nutrition was delivered to each mother. Before and after that maternal nutrition education, the anthropometric and biochemistry parameters of children were mesured.

    Impact of maternal education: 10 months

Study Arms (2)

Zinc supplementation

EXPERIMENTAL

The 25 supplemented children had received an oral dose of 10 mg of zinc sulphate per day for 14 days

Drug: Zinc Supplementation

Nutrition education of mothers

EXPERIMENTAL

Nutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education

Behavioral: Nutrition education of mothers

Interventions

The 25 supplemented children had received an oral zinc supplement per day for 14 days and had no dietary restrictions.

Also known as: Supplementation
Zinc supplementation

Nutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education

Also known as: Maternal education
Nutrition education of mothers

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • To have an age between 6 to 59 months
  • To have signature of informed consent by the parents

You may not qualify if:

  • To be illnes
  • To have severe malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dietary SupplementsEducational Status

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Evaluation of the anthropometric and biochemistry parameters of children before and after an intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Nutrition and Food Science Doctor)

Study Record Dates

First Submitted

September 15, 2020

First Posted

October 5, 2020

Study Start

March 1, 2015

Primary Completion

December 15, 2015

Study Completion

December 30, 2015

Last Updated

October 6, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

To share the data with other researchers, we want to publish our study to international review.