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Clinical Trial Details

Trial ID: L0042
Source ID: NCT03991169
Associated Drug: Ferrous Sulfate
Title: Oral Iron in Children With Chronic Kidney Disease
Acronym: FeTCh-CKD
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Insufficiency|Chronic Kidney Diseases
Interventions: DRUG: Ferrous Sulfate
Outcome Measures: Primary: Change in muscle strength, Hand-grip strength measured by a dynamometer, 0 and 3 months|Change in the percentage of transferrin saturation in the participants' blood, 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, 0 and 3 months | Secondary: Change in sedentary time, 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., 0 and 3 months|Change in the percent of skeletal muscle mass, Percent of skeletal muscle mass out of body weight will be measured using bio-electrical impedance analysis., 0 and 3 months|Change in eating behavior, 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"., 0 and 3 months|Change in quality of life: PROMIS, 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., 0 and 3 months
Sponsor/Collaborators: Sponsor: Weill Medical College of Cornell University | Collaborators: Children's Hospital of Philadelphia
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-19
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2024-10-01
Locations: Weill Cornell Medicine / New York Presbyterian Hospital, New York, New York, 10065, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
URL: https://clinicaltrials.gov/show/NCT03991169