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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04014855
Other study ID # 271182
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2018
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Iron Supplement
in iron deficiency anemia

Locations

Country Name City State
Egypt Marian Girgis Rizk Abdelsayed Cairo Non-US/Non-Canadian

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary iron deficiency anemia CBC and iron profile 3 months
Secondary weight Weight and body copmositiin 3 months
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