A Single High-dose Oral Supplement of Vitamin D in Young Chinese

Vitamin D Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158143
• Other study ID #: CRC-KY1301
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: June 5, 2014
• Start date: October 2013

Study information

• Verified date: June 2014
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 35 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D3

Locations

Country	Name	City	State
China	Institute for Nutrition Sciences, Chinese Academy of Sciences	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of vitamin D3 supplementation on serum 25(OH)D changes		within 140 day after supplementation	No
Primary	Effect of vitamin D3 supplementation on serum PTH		within 140 day after supplementation	No
Primary	Effect of vitamin D3 supplementation on serum calcium		within 140 day after supplementation	Yes
Primary	Effect of vitamin D3 supplementation on serum creatinine		within 140 day of supplementation	Yes
Primary	Effect of vitamin D3 supplementation on urinary calcium / creatinine		within 140 day after supplementation	Yes
Secondary	Effect of vitamin D3 supplementation on fasting blood glucose		within 140 day after supplementation	No
Secondary	Effect of vitamin D3 supplementation on serum lipids		within 140 day after supplementation	No