HealthyNCT01457365
Vitamin D Deficiency Epidemiological Research in Sichuan, China
An observational study of Healthy, run by West China Hospital at 1 site in China.
Trial summary
Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in China. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2012
- Phase
- Observational
- 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 30 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: In total, 1500 female subjects aged more than 30 years old (750 urban and 750 rural females) will be included
Who may be able to join
- Females aged 30 years old living in Sichuan province.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Status and Its Correlation to Bone Density, Bone Turnover Markers and Muscle Function in Community-dwelling People in Sichuan Province , P.R. China
Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in China. This study will research the serum 25OHD level to get the prevalence of vitamin D deficiency and insufficiency of urban and rural residents in Sichuan Province, China.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects | it is a cross-sectional research and there is only one group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25OHD
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Measured: 0 day.
serum calcium and phosphate, creatinine, PTH, BALP and CTX
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Measured: 0 day
Bone mineral density of lumbar spine and hip
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Measured: 0 day.
Short physical performance battery
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Measured: 0 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2012 (estimated)
- Study completionDec 2012 (estimated)
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 West China 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Decai Chen, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457365
- Sponsor's protocol ID
- IISP-VDCHINA
- Status last verified
- Oct 2011
- First submitted
- 17 Oct 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and Its Correlation to Bone Density, Bone Turnover Markers and Muscle Function in Community-dwelling People in Sichuan Province , P.R. China
- ClinicalTrials.gov ID
- NCT01457365
- Acronym / sponsor ID
- IISP-VDCHINA
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Oct 2011 (estimated)
- 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.
Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in China. This study will research the serum 25OHD level to get the prevalence of vitamin D deficiency and insufficiency of urban and rural residents in Sichuan Province, China.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects | – | –it is a cross-sectional research and there is only one group. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In total, 1500 female subjects aged more than 30 years old (750 urban and 750 rural females) will be included
Key inclusion criteria (1 listed)
- Females aged 30 years old living in Sichuan province.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25OHD
Time frame: 0 day.
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
serum calcium and phosphate, creatinine, PTH, BALP and CTX
Time frame: 0 day
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Bone mineral density of lumbar spine and hip
Time frame: 0 day.
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Short physical performance battery
Time frame: 0 day.
It is a cross-sectional study. All measurements will be performed once after subjects are enrolled.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by West China 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 21 Oct 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Wang, M.D., Ph.D. (+86 28 85422360, wq3166@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25OHD (time frame: 0 day.). The study lists 4 primary outcomes in all. 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 21 Oct 2011.