HealthyNCT03208075
the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men
A study testing normal diet, low-phosphorus diet and high-phosphorus diet in people with Healthy, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- normal diet, low-phosphorus diet and high-phosphorus diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan hospital, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- normal diet, low-phosphorus diet, high-phosphorus diet
- Keywords
- phosphorus,diet, phosphorus, healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal dietOther
Diet containing 1500mg of phosphorus
low-phosphorus dietOther
Diet containing 500mg of phosphorus
high-phosphorus dietOther
Diet containing 2300mg of phosphorus
| Study group | Role | What they receive |
|---|---|---|
| Normal Phosphorus Diet | Experimental | Diet containing 1500mg of phosphorus per day Receives: Other: normal diet |
| Low-phosphorus Diet | Experimental | Diet containing 500mg of phosphorus per day Receives: Other: low-phosphorus diet |
| High-phosphorus Die | Experimental | Diet containing 2300mg of phosphorus per day Receives: Other: high-phosphorus diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythm of serum phosphorus concentration
Measured: 24 hour
Secondary outcomes (4)
Circadian rhythm of urine phosphorus concentration
Measured: 24 hour
Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)
Measured: 24 hour
Circadian rhythm of parathyroid hormone (PTH)
Measured: 24 hour
Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Jun 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208075
- Sponsor's protocol ID
- HuashanH-2
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men
- ClinicalTrials.gov ID
- NCT03208075
- Acronym / sponsor ID
- HuashanH-2
- Conditions
- Healthy
- Keywords
- phosphorus,diet, phosphorus, healthy subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Phosphorus Diet | Experimental | Other: normal dietDiet containing 1500mg of phosphorus per day |
| Low-phosphorus Diet | Experimental | Other: low-phosphorus dietDiet containing 500mg of phosphorus per day |
| High-phosphorus Die | Experimental | Other: high-phosphorus dietDiet containing 2300mg of phosphorus per day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal dietDiet containing 1500mg of phosphorus | Other | Normal Phosphorus Diet |
| low-phosphorus dietDiet containing 500mg of phosphorus | Other | Low-phosphorus Diet |
| high-phosphorus dietDiet containing 2300mg of phosphorus | Other | High-phosphorus Die |
Primary outcome
Circadian rhythm of serum phosphorus concentration
Time frame: 24 hour
4 secondary outcomes
Circadian rhythm of urine phosphorus concentration
Time frame: 24 hour
Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)
Time frame: 24 hour
Circadian rhythm of parathyroid hormone (PTH)
Time frame: 24 hour
Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal diet, low-phosphorus diet and high-phosphorus diet in people with Healthy, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian rhythm of serum phosphorus concentration (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.