A Single High-dose Oral Supplement of Vitamin D in Young Chinese
1 other identifier
interventional
28
1 country
1
Brief Summary
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
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
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedJune 6, 2014
June 1, 2014
6 months
June 5, 2014
June 5, 2014
Conditions
Outcome Measures
Primary Outcomes (5)
Effect of vitamin D3 supplementation on serum 25(OH)D changes
within 140 day after supplementation
Effect of vitamin D3 supplementation on serum PTH
within 140 day after supplementation
Effect of vitamin D3 supplementation on serum calcium
within 140 day after supplementation
Effect of vitamin D3 supplementation on serum creatinine
within 140 day of supplementation
Effect of vitamin D3 supplementation on urinary calcium / creatinine
within 140 day after supplementation
Secondary Outcomes (2)
Effect of vitamin D3 supplementation on fasting blood glucose
within 140 day after supplementation
Effect of vitamin D3 supplementation on serum lipids
within 140 day after supplementation
Study Arms (1)
vitamin D3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years;
- haven't taken vitamin D supplement for the past 6 months;
- with a normal BMI (18-25 kg/m2);
- with baseline serum 25(OH)D \< 30 ng/ml;
- be willing to follow the instruction and complete the study.
You may not qualify if:
- clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness;
- self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment;
- Severe anemia (hemoglobin concentration \< 70 g/L);
- Serum 25(OH)D ≥ 30 ng/mL at enrollment;
- participating in other research studies within the 3 months before enrollment;
- history of drug dependence or drug abuse;
- History of heavy drinking (drinking 14 cups or more per week, equivalent to 360 mL beer or 150 mL white wine or 45 mL liquor per cup) and smokers (more than 10 cigarette per day);
- clinical abnormal of blood biochemistry, hematology or urine laboratory values;
- current pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Nutrition Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 6, 2014
Study Start
October 1, 2013
Primary Completion
April 1, 2014
Last Updated
June 6, 2014
Record last verified: 2014-06