UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000803 |
|---|---|
| Receipt number | R000000963 |
| Scientific Title | Studies on the effect of dietary phosphorus loading on the physiological function and determination of tolerable upper intake level of phosphorus in human. |
| Date of disclosure of the study information | 2007/08/31 |
| Last modified on | 2012/03/19 10:26:05 |
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Basic information
Public title
Studies on the effect of dietary phosphorus loading on the physiological function and determination of tolerable upper intake level of phosphorus in human.
Acronym
Dietary phosphorus loading trial in human.
Scientific Title
Studies on the effect of dietary phosphorus loading on the physiological function and determination of tolerable upper intake level of phosphorus in human.
Scientific Title:Acronym
Dietary phosphorus loading trial in human.
Region
| Japan |
Condition
Condition
Chronic Kidney Disease, Cardiovascular disease, metabolic bone disease
Classification by specialty
| Cardiology | Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of overintake of phosphorus on the regulation of mineral metabolism and cardiovascular function in human.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum P, serum Ca, intact PTH, intact FGF23, urinary P, urinary Ca, Flow-mediated dilation (FMD) before and after the meal ingestion (until 8h later).
Key secondary outcomes
Serum TG, serum glucose, serum creatinine, urinary creatinine before and after the meal ingestion (until 8h later).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
high phosphorus diet (Phosphorus 1200mg/meal, bolus) -> wash out period (al least 1day) -> control phosphorus diet (Phosphorus 400mg/meal, bolus)
Interventions/Control_2
control phosphorus diet (Phosphorus 400mg/meal, bolus) -> wash out period (al least 1day) -> high phosphorus diet (Phosphorus 1200mg/meal, bolus)
Interventions/Control_3
high phosphorus diet (Phosphorus 800mg/meal, bolus) -> wash out period (al least 1day) -> control phosphorus diet (Phosphorus 400mg/meal, bolus)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy men, non-smoker
Healthy women, non-smoker
Key exclusion criteria
hyperlipidemia, hypertension, kidney dysfunction, diabetes, cardiovascular disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Takeda |
Organization
University of Tokushima Graduate School,
Institute of Health Biosciences
Division name
Department of Clinical Nutrition
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7093
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Taketani |
Organization
University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Clinical Nutrition
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima, Japan
TEL
088-633-9597
Homepage URL
taketani@nutr.med.tokushima-u.ac.jp
Sponsor or person
Institute
Department of Clinical Nutrition, Institute of Health Biosciences, University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports Science, and Technology of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Agriculture, Forestry and Fisheries of Japan
The Kidney Foundation, Japan
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
徳島大学大学院ヘルスバイオサイエンス研究部（徳島県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
When the subjects ingested high phosphorus diet (1200mg/meal), serum phosphorus levels significantly increased at 2 hours after the meal ingestion. In addition, flow-mediated dilation (%FMD) of subjects also significantly decreased at 2 hours after high phosphorus diet ingestion, but not changed after control diet ingestion. These results suggest that acute increase in serum phosphorus level may be involved in endothelial dysfunction.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
This study still continue to examine the dose-dependent effect, time-course and gender effect of phosphorus loading on serum phosphorus levels, phosphorus regulating hormones and endothelial function in healthy persons.
Management information
Registered date
| 2007 | Year | 08 | Month | 18 | Day |
Last modified on
| 2012 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000963
