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

The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children

The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Drug: Iron Supplement

Detailed Description

Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Non-US/Non-Canadian
    • Cairo, Non-US/Non-Canadian, Egypt, 02
      • Marian Girgis Rizk Abdelsayed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: obese children 1; iron supplementation	Drug: Iron Supplement; in iron deficiency anemia; Other Names: lactoferrin
ACTIVE_COMPARATOR: obese children 2; lactoferrin supplementation	Drug: Iron Supplement; in iron deficiency anemia; Other Names: lactoferrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iron deficiency anemia	CBC and iron profile	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	Weight and body copmositiin	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Marian GR Abdelsayed, Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (ACTUAL): July 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Pediatric Obesity; Weight Loss; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: 271182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No