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

NCT ID: NCT04014855

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-07-01

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

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

obese children 1

iron supplementation

Group Type: ACTIVE_COMPARATOR

Iron Supplement

Intervention Type: DRUG

in iron deficiency anemia

obese children 2

lactoferrin supplementation

Group Type: ACTIVE_COMPARATOR

Iron Supplement

Intervention Type: DRUG

in iron deficiency anemia

Interventions

Iron Supplement

in iron deficiency anemia

Intervention Type: DRUG

Other Intervention Names

lactoferrin

Eligibility 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.

-

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Marian girgis

lecturer of paediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marian GR Abdelsayed

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Marian Girgis Rizk Abdelsayed

Cairo, Non-US/Non-Canadian, Egypt

Countries

Egypt

Other Identifiers

271182

Identifier Type: -

Identifier Source: org_study_id