Clinical trial NCT02040740: Mediators of Kidney-Bone Communication in Childhood
Official title: Pubertal Assessment of Kidney-Bone Crosstalk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting Blood Measures
Body Scans
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 26
Sex: MALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy boys ages 7-11y

Brief summary: An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23 (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves the body's overall needs. However, it is not clear as to whether this is true, particularly with growth. The contribution of dietary factors directly linked with the bone/kidney axis through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and urinary analysis) will be included in investigations. Findings will serve as a springboard for delineating more specific mechanisms by which these systems become disordered and are influenced by diet. It is expected that adequacy of nutrients known to have a central role in bone function will optimize the hormonal milieu through crosstalk with the kidney.

This effort will allow ongoing investigation in detecting and treating disturbances in mineral metabolism related to kidney disease, specifically in the pediatric population and broaden the understanding of kidney disease itself, as well as that of chronic diseases in which kidney health is of importance, such as diabetes and osteoporosis. Findings of this research may stress the importance of achieving dietary adequacy essential for establishing optimal body composition trajectories, particularly puberty.


Eligibility criteria: Inclusion Criteria:

* Male
* ages 7-11y
* Tanner stage less than or equal to 3 according to the criteria of Marshall and Tanner

Exclusion Criteria:

* History of Cushing's Syndrome, hyperprolactinemia, congenital (non-classic) adrenal hyperplasia, type 1 or 2 diabetes, disturbances in glucose or lipid metabolism
* use of tobacco or consumption of alcohol; thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
* eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease.

Primary outcomes:
measure: Fibroblast Growth Factor 23
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB, Nutrition Sciences
name: Krista Casazza, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: UAB, Department of Medicine
name: Orlando M Gutierrez, MD
role: STUDY_DIRECTOR
affiliation: UAB, Department of Medicine
name: Lynae J Hanks, PhD, RD
role: STUDY_DIRECTOR
affiliation: Children's of Alabama, Pediatric Endocrinology
name: Ambika P Ashraf, MD
role: STUDY_DIRECTOR
References:
citation: Hanks LJ, Gutierrez OM, Ashraf AP, Casazza K. Bone Mineral Content as a Driver of Energy Expenditure in Prepubertal and Early Pubertal Boys. J Pediatr. 2015 Jun;166(6):1397-403. doi: 10.1016/j.jpeds.2015.02.054. Epub 2015 Apr 1.