Oral Iron in Children With Chronic Kidney Disease

Phase 4

Recruiting

• Conditions: Chronic Kidney Insufficiency; Chronic Kidney Diseases
• Interventions: Drug: Ferrous Sulfate

• Registration Number: NCT03991169
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-19
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Iron therapy	Ferrous Sulfate	Participant will receive oral iron therapy.

Primary Outcome Measures

Name	Time	Method
Change in muscle strength	0 and 3 months	Hand-grip strength measured by a dynamometer
Change in the percentage of transferrin saturation in the participants' blood	0 and 3 months	Transferrin saturation is a medical laboratory value, measured as a percentage. It is the value of serum iron concentration divided by the total iron-binding capacity. For instance, a value of 15% means that 15% of iron-binding sites of transferrin are being occupied by iron.; Blood will be collected with the venopuncture used for clinically indicated blood tests at routine clinic visits

Secondary Outcome Measures

Name	Time	Method
Change in sedentary time	0 and 3 months	Sedentary time (in minutes per day) will be measured by actigraphy. Actigraph is a monitor that looks like a wristband or a watch that measures and records body movements throughout the day. Participating children will wear actigraphs for 7 days in the beginning and 7 days at the conclusion of the study.
Change in the percent of skeletal muscle mass	0 and 3 months	Percent of skeletal muscle mass out of body weight will be measured using bio-electrical impedance analysis.
Change in eating behavior	0 and 3 months	Appetite / eating behavior assessed using Children's Eating Behavior Questionnaire (CEBQ). It is a parent-report measure comprised of 35 items, each rated as "Never", "Rarely", "Sometimes", "Often", "Always". The answers will be grouped into the domains to assess eating styles of the participating children, such as: "Enjoyment of food", "Slowness in eating", "Emotional under-eating", "Food fussiness".
Change in quality of life: PROMIS	0 and 3 months	Quality of life will be assessed in the Fatigue, and Physical Activity domains using the Patient-Reported Outcomes Measurement Information System (PROMIS), developed by the National Institutes of Health. PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.; Higher scores will mean more Fatigue and more Physical Activity respectively.

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Weill Cornell Medicine / New York Presbyterian Hospital; 🇺🇸 New York, New York, United States