the Regulation of Phosphorus Homeostasis by Dietary Phosp... | NCT03208075

Studies
the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men

NCT03208075

Sponsor

Huashan Hospital

Status

Completed

Last Update Posted

Aug 15, 2017Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

normal diet
low-phosphorus diet
high-phosphorus diet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Aug 1, 2017Actual

First Submitted Date

Jul 2, 2017

First Submission Date that Met QC Criteria

Jul 2, 2017

First Posted Date

Jul 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2017

Last Update Posted Date

Aug 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators have conducted the study about the effects of normal diet and low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.

Detailed Description

Serum phosphate concentrations are not only associated with cardiovascular and all-cause mortality in chronic kidney disease (CKD) patients, but also associated with the mortality in community population. Thus, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for healthy people.

The investigators have conducted a study about the effects of normal diet (phosphorus 1500mg) and low-phosphorus diet (phosphorus 500mg) on phosphorus homeostasis in healthy men. The results showed low-phosphorus diet could significantly reduce serum phosphorus and urine phosphorus level compared to normal diet. However, the levels of serum FGF23 and a-klotho were not different between these two groups.Thus, the investigators want to further explore the effects of high-phosphorus diet (phosphorus 2300mg)on phosphorus homeostasis in healthy men.

Therefore, the investigators plan to conduct a crossover clinical study to evaluate the phosphorus homeostasis modulated by native normal diet, restricted phosphorus diet, high phosphorus diet and then to explore the underlying mechanisms.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Phosphorus Diet	Experimental	Diet containing 1500mg of phosphorus per day	Other: normal diet
Low-phosphorus Diet	Experimental	Diet containing 500mg of phosphorus per day	Other: low-phosphorus diet
High-phosphorus Die	Experimental	Diet containing 2300mg of phosphorus per day	Other: high-phosphorus diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
normal diet	Other	Diet containing 1500mg of phosphorus	Normal Phosphorus Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circadian rhythm of serum phosphorus concentration		24 hour

Secondary Outcomes

Measure	Description	Time Frame
Circadian rhythm of urine phosphorus concentration		24 hour
Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)		24 hour
Circadian rhythm of parathyroid hormone (PTH)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men aged 18-45 years
Healthy volunteers: no history of chronic diseases; no active symptoms or physical signs; negative results of electrocardiogram and chest X-ray; biochemical indicators of regular medical examination are within 95%-105% of normal range.
Willingness to sign the consent form approved by an Institutional Review Board and comply with the study protocol.
Body mass index ranged within 18.5-24 kg/m2.

Exclusion Criteria:

Current history of drug or alcohol abuse as assessed by the principal Investigator.
Subject has blood donations or blood loss more than 300ml within three months
Allergic to more than two foods or drugs.
Subject has psycho-disability or body disability.
Subject has a condition that in the judgment of the Principal Investigator could potentially pose a health risk to the patient while involved in the study.
Subject has participated in the other clinical trials at the same time.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan hospital, Shanghai Medical College, Fudan University		Shanghai	Shanghai Municipality	200040	China