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出境医 / 临床实验 / Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children

Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children

Study Description
Brief Summary:
The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children

Condition or disease Intervention/treatment Phase
Obesity, Childhood Drug: Iron Supplement Phase 4

Detailed Description:
Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: obese children 1
iron supplementation
 Drug: Iron Supplement
in iron deficiency anemia
Other Name: lactoferrin
Active Comparator: obese children 2
lactoferrin supplementation
 Drug: Iron Supplement
in iron deficiency anemia
Other Name: lactoferrin
Outcome Measures
Primary Outcome Measures :
  1. iron deficiency anemia [ Time Frame: 3 months ]
    CBC and iron profile


Secondary Outcome Measures :
  1. weight [ Time Frame: 3 months ]
    Weight and body copmositiin


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. children age will be between 6 -12 years old. 2. Presence of iron deficiency anemia, it will be diagnosed by

    • CBC >> Hemoglobin level concentration below 11.5 g/dl.
    • level of serum iron is below 30 µmol/l,
    • level of ferritin is below 15 µg/dl

    • Total iron binding capacity is more 480 µg/dlL. 3. children should be stable and free from chronic disease. 4. Body Mass index (BMI) should be ≥the 95th percentile for children and teens of the same age and sex.

      5. there is not history of iron supplements in the 3 months before treatment.

Exclusion Criteria:

  1. Father/mother refuses to participate in the study.
  2. Hospitalized patient.
  3. Non-anemic patient.
  4. Patients receiving iron supplements 3 months before enrollment.
  5. Patients with chronic diseases.
  6. personal or family history of allergy to cow's milk or infant formula, eczema, moderate-to-severe allergic rhinitis or asthma, or milk intolerance.
  7. severe anemia as Hemoglobin level concentration below 7 g/dl.

Exclusion Criteria:

-

Contacts and Locations

Locations
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Egypt
Marian Girgis Rizk Abdelsayed
Cairo, Non-US/Non-Canadian, Egypt, 02
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Marian GR Abdelsayed Ain Shams University
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		iron deficiency anemia [ Time Frame: 3 months ]
CBC and iron profile
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		weight [ Time Frame: 3 months ]
Weight and body copmositiin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children
Official Title  ICMJE The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children
Brief Summary The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children
Detailed Description Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Obesity, Childhood
Intervention  ICMJE Drug: Iron Supplement
in iron deficiency anemia
Other Name: lactoferrin
Study Arms  ICMJE
  • Active Comparator: obese children 1
    iron supplementation
    Intervention: Drug: Iron Supplement
  • Active Comparator: obese children 2
    lactoferrin supplementation
    Intervention: Drug: Iron Supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019) 		50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. children age will be between 6 -12 years old. 2. Presence of iron deficiency anemia, it will be diagnosed by

    • CBC >> Hemoglobin level concentration below 11.5 g/dl.
    • level of serum iron is below 30 µmol/l,
    • level of ferritin is below 15 µg/dl

    • Total iron binding capacity is more 480 µg/dlL. 3. children should be stable and free from chronic disease. 4. Body Mass index (BMI) should be ≥the 95th percentile for children and teens of the same age and sex.

      5. there is not history of iron supplements in the 3 months before treatment.

Exclusion Criteria:

  1. Father/mother refuses to participate in the study.
  2. Hospitalized patient.
  3. Non-anemic patient.
  4. Patients receiving iron supplements 3 months before enrollment.
  5. Patients with chronic diseases.
  6. personal or family history of allergy to cow's milk or infant formula, eczema, moderate-to-severe allergic rhinitis or asthma, or milk intolerance.
  7. severe anemia as Hemoglobin level concentration below 7 g/dl.

Exclusion Criteria:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014855
Other Study ID Numbers  ICMJE 271182
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marian girgis, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marian GR Abdelsayed Ain Shams University
PRS Account Ain Shams University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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