- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574544
Zinc Supplementation and Nutrition Education Among Children in the Rural Community
October 2, 2020 updated by: NOLLA Nicolas Policarpe, University of Douala
Pilot Zinc Supplementation and Nutrition Education Among Children in the Rural Community, Cameroon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A questionnaire was developed, tested and adjusted prior the field survey.
During the study, the knowledge of mothers on child nutrition, the eating habits of children, the estimated consumption of energy, nutrients of children and food availability on the market during harvesting and sowing seasons were evaluated.
Moreover, data on zinc supplementation and nutrition education sessions conducted with mothers of these children were collected.
The impact of zinc supplementation and maternal education was evaluated by measuring height/age, weight/age and weight/height indices, and levels of serum albumin, calcium, zinc, iron, magnesium and phosphorus before and after interventions.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To have an age between 6 to 59 months
- To have signature of informed consent by the parents
Exclusion Criteria:
- To be illnes
- To have severe malnutrition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zinc supplementation
The 25 supplemented children had received an oral dose of 10 mg of zinc sulphate per day for 14 days
|
The 25 supplemented children had received an oral zinc supplement per day for 14 days and had no dietary restrictions.
Other Names:
|
Experimental: Nutrition education of mothers
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Zinc supplementation among children in the rural community
Time Frame: Zinc supplementation: 14 days
|
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
Time Frame: Impact of maternal education: 10 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
December 15, 2015
Study Completion (Actual)
December 30, 2015
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 28, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 6, 2020
Last Update Submitted That Met QC Criteria
October 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- UDouala
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
To share the data with other researchers, we want to publish our study to international review.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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