Hormonal changes induced by changing amounts of protein and phosphorus in the diet of healthy volunteers
| ISRCTN | ISRCTN10876564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10876564 |
| Secondary identifying numbers | 2008/155 |
- Submission date
- 06/05/2010
- Registration date
- 27/05/2010
- Last edited
- 30/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marc Vervloet
Scientific
Scientific
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | 31-20-4442673 |
|---|---|
| m.vervloet@vumc.nl |
Study information
| Study design | Non-randomised controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Effects of changes in dietary phosphorus intake on fibroblast growth factor 23 (FGF23) levels in healthy volunteers: a controlled crossover trial |
| Study objectives | Background: This study is related to patients with kidney disease. Kidney disease, as defined by a decline in estimated Glomerular Filtration Rate (GFR), as even in early stages related to disturbances in the metabolism of minerals, especially calcium and phosphorus, and Fibroblast growth factor 23 (FGF23). The latter is related to clinical endpoints and mortality. Hypothesis Changes in phosphate intake lead to parallel changes in levels of FGF23, even in healthy volunteers. These changes in FGF23 in turn lead to increases in phosphaturia and changes in levels of 1,25 dihydroxyvitamin D, both independent from possible changes in PTH or serum phosphate levels. |
| Ethics approval(s) | The local medical ethics committe (Medisch Ethische Toetsingscommissie) of Vrije University Medical Centre (VUMC) approved on the 11th of August 2008 (ref: 2008/155) |
| Health condition(s) or problem(s) studied | Kidney disease |
| Intervention | Subjects are switched from regular diet to phosphate-restricted diet for two days, and the back to regular diet for ten days. After that they are switched from regular diet to phopsphate-enriched diet and the back again. No other interventions are made. Both the primary and secondary endpoint were determined during the interventional periods, because changes induced by the intervention are almost immediate. |
| Intervention type | Other |
| Primary outcome measure | Changes in FGF23 levels, determined using sandwich ELISA for both C-terminal FGF23 (provided by Immutopics, San Clemente, USA) and Intact FGF23 (provided by Kainos, Japan). |
| Secondary outcome measures | 1. Changes in phosphaturia 2. Changes in levels of metaboliotes of vitamin D (1,25 dihydroxyvitamin D) Outcomes analysed by standard laboratory techniques and radio-immuno assay (IDS, Tyne and Wear, UK) respectively |
| Overall study start date | 01/08/2008 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Male or female 2. Non-smoking subjects 3. Normal renal function, as defined by estimated Glomerular Filtration Rate (GFR) above 80 ml/min. 4. Females should have a negative test for pregnancy at baseline |
| Key exclusion criteria | 1. Abnormal kidney function 2. Substantial comorbidity |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Nephrology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| m.vervloet@vumc.nl | |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
Vrije University Medical Centre (VUMC) (Netherlands) - Departments of nephrology and biochemistry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
