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

Primary Purpose

Obesity, Childhood

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Iron Supplement

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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:

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

Exclusion Criteria:

Sites / Locations

Marian Girgis Rizk Abdelsayed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

obese children 1

obese children 2

Arm Description

iron supplementation

lactoferrin supplementation

Outcomes

Primary Outcome Measures

iron deficiency anemia

CBC and iron profile

Secondary Outcome Measures

weight

Weight and body copmositiin

Full Information

NCT ID

NCT04014855

First Posted

July 8, 2019

Last Updated

July 9, 2019

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04014855

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

July 1, 2019 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Childhood

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

obese children 1

Arm Type

Active Comparator

Arm Description

iron supplementation

Arm Title

obese children 2

Arm Type

Active Comparator

Arm Description

lactoferrin supplementation

Intervention Type

Drug

Intervention Name(s)

Iron Supplement

Other Intervention Name(s)

lactoferrin

Intervention Description

in iron deficiency anemia

Primary Outcome Measure Information:

Title

iron deficiency anemia

Description

CBC and iron profile

Time Frame

3 months

Secondary Outcome Measure Information:

Title

weight

Description

Weight and body copmositiin

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marian GR Abdelsayed

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marian Girgis Rizk Abdelsayed

City

Cairo

State/Province

Non-US/Non-Canadian

ZIP/Postal Code

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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