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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Oral iron will be given in the form of immediate-release iron sulfate, 3-6 mg/kg/day of elemental iron to children with body weight ≤43 kg, and 65 mg of elemental iron (325 mg of iron sulfate) to children with body weight \>43 kg.
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGChange in muscle strength
Hand-grip strength measured by a dynamometer
Time frame: 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
Time frame: 0 and 3 months
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.
Time frame: 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.
Time frame: 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".
Time frame: 0 and 3 months
Change in quality of life: PROMIS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 0 and 3 months