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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: vitamin D3

• Registration Number: NCT02158143
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-04
• Status Verified: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-06
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamin D3	vitamin D3	-

Primary Outcome Measures

Name	Time	Method
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 25(OH)D changes	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute for Nutrition Sciences, Chinese Academy of Sciences; 🇨🇳 Shanghai, Shanghai, China