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

Phase 4

Completed

• Conditions: Obesity, Childhood
• Interventions: Drug: Iron Supplement

• Registration Number: NCT04014855
• Lead Sponsor: 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

Detailed Description

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

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Read More

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:

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
obese children 1	Iron Supplement	iron supplementation
obese children 2	Iron Supplement	lactoferrin supplementation

Primary Outcome Measures

Name	Time	Method
iron deficiency anemia	3 months	CBC and iron profile

Secondary Outcome Measures

Name	Time	Method
weight	3 months	Weight and body copmositiin

Trial Locations

Locations (1)

Marian Girgis Rizk Abdelsayed; 🇪🇬 Cairo, Non-US/Non-Canadian, Egypt