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Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese 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: NCT04014855
Recruitment Status : Completed
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Marian girgis, Ain Shams University

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

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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


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




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



Information from the National Library of Medicine

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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:

-


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): NCT04014855


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

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Responsible Party: Marian girgis, lecturer of paediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT04014855    
Other Study ID Numbers: 271182
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Iron
Lactoferrin
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents