Vitamin D DeficiencyNCT03339427
Intervention Study of Vitamin D Supplementation to Prevent Cardiovascular Disease
A study testing vitamin D in people with Vitamin D Deficiency, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2015
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. (Trial- related activities are any procedure that would not have been performed during normal management of the subject.)
- 25OHD<30ng/ml
Who cannot join
- Severe systemic disease (including severe heart, liver, kidney and lung diseases, severe infection, mental disorder and connective tissue disease)
- Primary hyperparathyroidism, other bone disease, malabsorption and other chronic gastrointestinal disease.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
- Use of systemic or inhaled glucocorticoids or other medication known to interfere with bone metabolism.
- Use of vitamin D related agents in recent 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Vitamin D Deficiency on Cardiovascular Disease and the Effect of Vitamin D Supplementation
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China.
Read the detailed description
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China.
Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 300 subjects with vitamin D insufficiency or deficiency will be included in this study. All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX and muscle power and balance.
After baseline data are collected, eligible subjects will be randomized into each group at a 1:1 ratio (150 for control group and 150 for vitamin D supplementation group, less than 20% drop-off rate is acceptable for this study). The initial vitamin D doses will be based on 25OHD levels at basis, and this dosage may be changed according be the level of 25OHD until the end of this study.
All subjects in the control group will be followed every half year. All subjects in the vitamin D group will be followed by visiting clinic, and will be titrated their doses. Dose adjustment should be aimed at achieving the following 25OHD targets: 30ng/ml. If above 25OHD target has not been achieved, vitamin D dose should be adjusted. Clinic visit will be conducted 3 months later to collect information, such as serum calcium, 25OHD and adverse events.
Complicated examinations will be repeated again after 9 months treatments for both groups, including physical examination, liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX and muscle power and balance. Data will be collected and analyzed.
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D, control
- Keywords
- vitamin D, cardiovascular, muscle power
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DOther
different doses of vitamin D supplementation
controlOther
control group
| Study group | Role | What they receive |
|---|---|---|
| vitamin D,capsule | Active comparator | A total of 150 subjects were recruited in the vitamin D supplementation group. Receives: Other: vitamin D |
| control | Other | A total of 150 subjects were recruited in the control group. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy on serum 25(OH)VitD level
The change of serum 25(OH)VitD level after vitamin D supplementation
Measured: 9 months
The efficacy on metabolic syndrome
The change of metabolic syndrome after vitamin D supplementation
Measured: 9 months
Secondary outcomes (4)
The efficacy on bone biomarkers
The change of bone biomarkers after vitamin D supplementation
Measured: 9 months
The efficacy on blood pressure
The change of blood pressure after vitamin D supplementation
Measured: 9 months
The efficacy on blood lipid
The change of blood lipid after vitamin D supplementation
Measured: 9 months
The efficacy on blood glucose
The change of blood glucose after vitamin D supplementation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study startJun 2014
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunlin Li, Chinese PLA General Hospital
- Investigators
- Chunlin Li, M.D&Ph.D, Principal investigator, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339427
- Sponsor's protocol ID
- VitD301
- Status last verified
- Nov 2017
- First submitted
- 19 Jun 2014
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vitamin D Deficiency on Cardiovascular Disease and the Effect of Vitamin D Supplementation
- ClinicalTrials.gov ID
- NCT03339427
- Acronym / sponsor ID
- VitD301
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, cardiovascular, muscle power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Nov 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.
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China.
Detailed description
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China.
Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 300 subjects with vitamin D insufficiency or deficiency will be included in this study. All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX and muscle power and balance.
After baseline data are collected, eligible subjects will be randomized into each group at a 1:1 ratio (150 for control group and 150 for vitamin D supplementation group, less than 20% drop-off rate is acceptable for this study). The initial vitamin D doses will be based on 25OHD levels at basis, and this dosage may be changed according be the level of 25OHD until the end of this study.
All subjects in the control group will be followed every half year. All subjects in the vitamin D group will be followed by visiting clinic, and will be titrated their doses. Dose adjustment should be aimed at achieving the following 25OHD targets: 30ng/ml. If above 25OHD target has not been achieved, vitamin D dose should be adjusted. Clinic visit will be conducted 3 months later to collect information, such as serum calcium, 25OHD and adverse events.
Complicated examinations will be repeated again after 9 months treatments for both groups, including physical examination, liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX and muscle power and balance. Data will be collected and analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D,capsule | Active comparator | Other: vitamin DA total of 150 subjects were recruited in the vitamin D supplementation group. |
| control | Other | Other: controlA total of 150 subjects were recruited in the control group. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent obtained before any trial-related activities. (Trial- related activities are any procedure that would not have been performed during normal management of the subject.)
- 25OHD<30ng/ml
Key exclusion criteria (5 listed)
- Severe systemic disease (including severe heart, liver, kidney and lung diseases, severe infection, mental disorder and connective tissue disease)
- Primary hyperparathyroidism, other bone disease, malabsorption and other chronic gastrointestinal disease.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
- Use of systemic or inhaled glucocorticoids or other medication known to interfere with bone metabolism.
- Use of vitamin D related agents in recent 3 months.
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 |
|---|---|---|
| vitamin Ddifferent doses of vitamin D supplementation | Other | vitamin D,capsule |
| controlcontrol group | Other | control |
Primary outcome
The efficacy on serum 25(OH)VitD level
Time frame: 9 months
The change of serum 25(OH)VitD level after vitamin D supplementation
The efficacy on metabolic syndrome
Time frame: 9 months
The change of metabolic syndrome after vitamin D supplementation
4 secondary outcomes
The efficacy on bone biomarkers
Time frame: 9 months
The efficacy on blood pressure
Time frame: 9 months
The efficacy on blood lipid
Time frame: 9 months
The efficacy on blood glucose
Time frame: 9 months
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 13 Nov 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.
Chunlin Li, M.D&Ph.D principal investigator
PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Vitamin D Deficiency, run by Chinese PLA General 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 2 inclusion and 5 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 13 Nov 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?
The efficacy on serum 25(OH)VitD level (time frame: 9 months). The study lists 2 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 13 Nov 2017.