- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098810
Effect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children
March 31, 2017 updated by: Marian girgis, Ain Shams University
Effect of Zinc Supplementation on Appetite and Growth of Primary Malnourished Children
Zinc supplementation effect on appetite and growth of malnourished children
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The investigators will do s.
Zinc and letting before and after zinc supplementation
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
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
2 years to 10 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary malnourished
Exclusion Criteria:
- zinc supplementation in the previous 3 months Children with chronic disease
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: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Normal children
Placebo
|
Oral syrup placebo
|
EXPERIMENTAL: Malnourished children
Oral zinc sulphate syrup
|
Oral syrup zinc sulphate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite
Time Frame: From start of supplementation to the end of the three months of supplementation
|
Child eating behavior questionnaire
|
From start of supplementation to the end of the three months of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: From start of supplementation to the end of the three months of supplementation
|
Weight
|
From start of supplementation to the end of the three months of supplementation
|
Height
Time Frame: From start of supplementation to the end of the three months of supplementation
|
Height
|
From start of supplementation to the end of the three months of supplementation
|
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 (ANTICIPATED)
April 1, 2017
Primary Completion (ANTICIPATED)
September 1, 2017
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 31, 2017
First Posted (ACTUAL)
April 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 4, 2017
Last Update Submitted That Met QC Criteria
March 31, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2272009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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