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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Institute for Nutrition Sciences, Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitamin D3	Dietary supplement: vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 6, 2014
• Last Update Submitted That Met QC Criteria: June 5, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CRC-KY1301