Back to resultsFolic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
Primary Purpose
Primary Malnurtrition
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Primary Malnurtrition
Eligibility Criteria
Inclusion Criteria:
Primary malnourished children
Exclusion Criteria:
- previous folic supplementation in the past 3 months
Sites / Locations
- Marian girgis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment group
Control
Arm Description
Outcomes
Primary Outcome Measures
Appetite
Child eating behaviour questionnaire
Secondary Outcome Measures
Leptin and ghrelin hormone
Serum level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03040219
Brief Title
Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
Official Title
Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and 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
November 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.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Folic acid as a appetizer in primary malnutrition
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Malnurtrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Appetite
Description
Child eating behaviour questionnaire
Time Frame
Through study completion_ after 3 months from start of supplementation
Secondary Outcome Measure Information:
Title
Leptin and ghrelin hormone
Description
Serum level
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Growth
Description
Anthropometric study
Time Frame
Through study completion -after 3 months from start of supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary malnourished children
Exclusion Criteria:
previous folic supplementation in the past 3 months
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
Facility Information:
Facility Name
Marian girgis
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian Girgis
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
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