Mediators of Kidney-Bone Communication in Childhood

NCT ID: NCT02040740

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Fasting Blood Measures; Body Scans

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Observation

Healthy early pubertal boys

No interventions assigned to this group

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Krista Casazza

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krista Casazza, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

UAB, Nutrition Sciences

Orlando M Gutierrez, MD

Role: STUDY_DIRECTOR

UAB, Department of Medicine

Lynae J Hanks, PhD, RD

Role: STUDY_DIRECTOR

UAB, Department of Medicine

Ambika P Ashraf, MD

Role: STUDY_DIRECTOR

Children's of Alabama, Pediatric Endocrinology

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25841541 (View on PubMed)

Other Identifiers

PAKC

Identifier Type: -

Identifier Source: org_study_id