Obesity, Childhood Clinical Trial
Official title:
The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children
| 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 |
| Verified date | July 2019 |
| Source | Ain Shams University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children
| 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Marian Girgis Rizk Abdelsayed | Cairo | Non-US/Non-Canadian |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
| 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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