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

Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name