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Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040219
Recruitment Status : Unknown
Verified March 2017 by Marian girgis, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Marian girgis, Ain Shams University

Study Description
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Brief Summary:
Folic acid as a appetizer in primary malnutrition

Condition or disease Intervention/treatment Phase
Primary Malnurtrition Drug: Folic Acid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
Estimated Study Start Date : April 1, 2017
Estimated Primary Completion Date : November 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment group Drug: Folic Acid
Tablets
Placebo Comparator: Control Drug: Folic Acid
Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Appetite [ Time Frame: Through study completion_ after 3 months from start of supplementation ]
    Child eating behaviour questionnaire


Secondary Outcome Measures :
  1. Leptin and ghrelin hormone [ Time Frame: 3 months ]
    Serum level


Other Outcome Measures:
  1. Growth [ Time Frame: Through study completion -after 3 months from start of supplementation ]
    Anthropometric study


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Primary malnourished children

Exclusion Criteria:

  • previous folic supplementation in the past 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040219


Contacts
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Contact: Marian Girgis 0201223646224 Mariangirgis2009@yahoo.com

Locations
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Egypt
Marian girgis
Cairo, Egypt
Contact: Marian Girgis         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Marian Girgis Ain Shams University
More Information
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Responsible Party: Marian girgis, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03040219    
Other Study ID Numbers: 27111982
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Folic Acid
Hematinics
Vitamin B Complex
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs