Intervention Study of Vitamin D Supplementation to Prevent Cardiovascular Disease
Study of Vitamin D Deficiency on Cardiovascular Disease and the Effect of Vitamin D Supplementation
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
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, 2014
CompletedFirst Submitted
Initial submission to the registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedNovember 13, 2017
November 1, 2017
7 months
June 19, 2014
November 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The efficacy on serum 25(OH)VitD level
The change of serum 25(OH)VitD level after vitamin D supplementation
9 months
The efficacy on metabolic syndrome
The change of metabolic syndrome after vitamin D supplementation
9 months
Secondary Outcomes (4)
The efficacy on bone biomarkers
9 months
The efficacy on blood pressure
9 months
The efficacy on blood lipid
9 months
The efficacy on blood glucose
9 months
Study Arms (2)
vitamin D,capsule
ACTIVE COMPARATORA total of 150 subjects were recruited in the vitamin D supplementation group.
control
OTHERA total of 150 subjects were recruited in the control group.
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
- OHD\<30ng/ml
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunlin Li, M.D&Ph.D
PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 19, 2014
First Posted
November 13, 2017
Study Start
June 1, 2014
Primary Completion
January 1, 2015
Study Completion
June 1, 2015
Last Updated
November 13, 2017
Record last verified: 2017-11