Back to resultsA Single High-dose Oral Supplement of Vitamin D in Young Chinese
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Institute for Nutrition Sciences, Chinese Academy of Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vitamin D3
Arm Description
Outcomes
Primary Outcome Measures
Effect of vitamin D3 supplementation on serum 25(OH)D changes
Effect of vitamin D3 supplementation on serum PTH
Effect of vitamin D3 supplementation on serum calcium
Effect of vitamin D3 supplementation on serum creatinine
Effect of vitamin D3 supplementation on urinary calcium / creatinine
Secondary Outcome Measures
Effect of vitamin D3 supplementation on fasting blood glucose
Effect of vitamin D3 supplementation on serum lipids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02158143
Brief Title
A Single High-dose Oral Supplement of Vitamin D in Young Chinese
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
4. Oversight
5. Study Description
Brief Summary
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D3
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Primary Outcome Measure Information:
Title
Effect of vitamin D3 supplementation on serum 25(OH)D changes
Time Frame
within 140 day after supplementation
Title
Effect of vitamin D3 supplementation on serum PTH
Time Frame
within 140 day after supplementation
Title
Effect of vitamin D3 supplementation on serum calcium
Time Frame
within 140 day after supplementation
Title
Effect of vitamin D3 supplementation on serum creatinine
Time Frame
within 140 day of supplementation
Title
Effect of vitamin D3 supplementation on urinary calcium / creatinine
Time Frame
within 140 day after supplementation
Secondary Outcome Measure Information:
Title
Effect of vitamin D3 supplementation on fasting blood glucose
Time Frame
within 140 day after supplementation
Title
Effect of vitamin D3 supplementation on serum lipids
Time Frame
within 140 day after supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Institute for Nutrition Sciences, Chinese Academy of Sciences
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
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A Single High-dose Oral Supplement of Vitamin D in Young Chinese
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