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

NCT04014855 | Completed Phase 4

• 1 other identifier: 271182
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• iron deficiency anemia

  CBC and iron profile

  3 months

Secondary Outcomes (1)

• weight

  3 months

Study Arms (2)

obese children 1

ACTIVE COMPARATOR

iron supplementation

Drug: Iron Supplement

obese children 2

ACTIVE COMPARATOR

lactoferrin supplementation

Drug: Iron Supplement

Interventions

Iron Supplement DRUG

in iron deficiency anemia

Also known as: lactoferrin

obese children 1; obese children 2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.
• \. there is not history of iron supplements in the 3 months before treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Marian Girgis Rizk Abdelsayed

Cairo, Non-US/Non-Canadian, 02, Egypt

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Iron-Dextran Complex; Lactoferrin

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Marian GR Abdelsayed

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of paediatrics

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: October 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)