Intervention Study of Vitamin D Supplementation to Prevent Cardiovascular Disease
NCT ID: NCT03339427
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2014-06-30
2015-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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vitamin D,capsule
A total of 150 subjects were recruited in the vitamin D supplementation group.
vitamin D
different doses of vitamin D supplementation
control
A total of 150 subjects were recruited in the control group.
control
control group
Interventions
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vitamin D
different doses of vitamin D supplementation
control
control group
Eligibility Criteria
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Inclusion Criteria
2. 25OHD\<30ng/ml
Exclusion Criteria
2. Primary hyperparathyroidism, other bone disease, malabsorption and other chronic gastrointestinal disease.
3. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
4. Use of systemic or inhaled glucocorticoids or other medication known to interfere with bone metabolism.
5. Use of vitamin D related agents in recent 3 months.
20 Years
90 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Chunlin Li
Professor
Principal Investigators
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Chunlin Li, M.D&Ph.D
Role: PRINCIPAL_INVESTIGATOR
PLA General Hospital
Locations
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PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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VitD301
Identifier Type: -
Identifier Source: org_study_id