Fasting Blood MeasuresPAKCNCT02040740
Mediators of Kidney-Bone Communication in Childhood
An observational study of Fasting Blood Measures and Body Scans, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting Blood Measures, Body Scans
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Healthy boys ages 7-11y
Who may be able to join
- Male
- ages 7-11y
- Tanner stage less than or equal to 3 according to the criteria of Marshall and Tanner
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Pubertal Assessment of Kidney-Bone Crosstalk
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Healthy early pubertal boys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast Growth Factor 23
Fasting plasma measure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fasting Blood MeasuresStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Casazza, University of Alabama at Birmingham
- Investigators
- Krista Casazza, PhD, RD, Principal investigator, UAB, Nutrition SciencesOrlando M Gutierrez, MD, Study director, UAB, Department of MedicineLynae J Hanks, PhD, RD, Study director, UAB, Department of MedicineAmbika P Ashraf, MD, Study director, Children's of Alabama, Pediatric Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040740
- Sponsor's protocol ID
- PAKC
- Acronym
- PAKC
- Status last verified
- Nov 2019
- First submitted
- 20 Dec 2013
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25841541
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pubertal Assessment of Kidney-Bone Crosstalk
- ClinicalTrials.gov ID
- NCT02040740
- Acronym / sponsor ID
- PAKC / PAKC
- Conditions
- Fasting Blood Measures, Body Scans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Healthy early pubertal boys |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy boys ages 7-11y
Key inclusion criteria (3 listed)
- Male
- ages 7-11y
- Tanner stage less than or equal to 3 according to the criteria of Marshall and Tanner
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibroblast Growth Factor 23
Time frame: 1 day
Fasting plasma measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 25841541Hanks 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.
Related trials for Fasting Blood Measures
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Intermittent Fasting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Casazza, PhD, RD principal investigator
UAB, Nutrition Sciences
Orlando M Gutierrez, MD study director
UAB, Department of Medicine
Lynae J Hanks, PhD, RD study director
UAB, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting Blood Measures and Body Scans, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast Growth Factor 23 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.