PAKC: Mediators of Kidney-Bone Communication in Childhood

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT02040740

Collaborator

(none)

Enrollment

Location

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fasting Blood Measures Body Scans

Study Design

Study Type:

Observational

Actual Enrollment :

26 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Pubertal Assessment of Kidney-Bone Crosstalk

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Observation Healthy early pubertal boys

Outcome Measures

Primary Outcome Measures

Fibroblast Growth Factor 23 [1 day]
Fasting plasma measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Krista Casazza, PhD, RD, UAB, Nutrition Sciences
Study Director: Orlando M Gutierrez, MD, UAB, Department of Medicine
Study Director: Lynae J Hanks, PhD, RD, UAB, Department of Medicine
Study Director: Ambika P Ashraf, MD, Children's of Alabama, Pediatric Endocrinology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Krista Casazza, Assistant Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT02040740

Other Study ID Numbers:

PAKC

First Posted:

Jan 20, 2014

Last Update Posted:

Nov 25, 2019

Last Verified:

Nov 1, 2019

Study Results

No Results Posted as of Nov 25, 2019