Back to resultsEffect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children
Primary Purpose
Appetite Disorders
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zinc sulphate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Appetite Disorders
Eligibility Criteria
Inclusion Criteria:
- primary malnourished
Exclusion Criteria:
- zinc supplementation in the previous 3 months Children with chronic disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Normal children
Malnourished children
Arm Description
Placebo
Oral zinc sulphate syrup
Outcomes
Primary Outcome Measures
Appetite
Child eating behavior questionnaire
Secondary Outcome Measures
Weight
Weight
Height
Height
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03098810
Brief Title
Effect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children
Official Title
Effect of Zinc Supplementation on Appetite and Growth of Primary Malnourished Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Anticipated)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Zinc supplementation effect on appetite and growth of malnourished children
Detailed Description
The investigators will do s. Zinc and letting before and after zinc supplementation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal children
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Malnourished children
Arm Type
Experimental
Arm Description
Oral zinc sulphate syrup
Intervention Type
Drug
Intervention Name(s)
Zinc sulphate
Intervention Description
Oral syrup zinc sulphate
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral syrup placebo
Primary Outcome Measure Information:
Title
Appetite
Description
Child eating behavior questionnaire
Time Frame
From start of supplementation to the end of the three months of supplementation
Secondary Outcome Measure Information:
Title
Weight
Description
Weight
Time Frame
From start of supplementation to the end of the three months of supplementation
Title
Height
Description
Height
Time Frame
From start of supplementation to the end of the three months of supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary malnourished
Exclusion Criteria:
zinc supplementation in the previous 3 months Children with chronic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Girgis
Phone
0201223646224
Email
mariangirgis2009@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Girgis
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children
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