the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jun 2017
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 2, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 15, 2017
August 1, 2017
2 months
July 2, 2017
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Circadian rhythm of serum phosphorus concentration
24 hour
Secondary Outcomes (4)
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)
24 hour
Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)
24 hour
Study Arms (3)
Normal Phosphorus Diet
EXPERIMENTALDiet containing 1500mg of phosphorus per day
Low-phosphorus Diet
EXPERIMENTALDiet containing 500mg of phosphorus per day
High-phosphorus Die
EXPERIMENTALDiet containing 2300mg of phosphorus per day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (1)
Huashan hospital, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 2, 2017
First Posted
July 5, 2017
Study Start
June 1, 2017
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 15, 2017
Record last verified: 2017-08