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

• Sponsor: Chinese Academy of Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02158143
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Dietary Supplement: vitamin D3	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vitamin D3	Dietary Supplement: vitamin D3

Outcome Measures

Primary Outcome Measures

1. Effect of vitamin D3 supplementation on serum 25(OH)D changes [within 140 day after supplementation]

2. Effect of vitamin D3 supplementation on serum PTH [within 140 day after supplementation]

3. Effect of vitamin D3 supplementation on serum calcium [within 140 day after supplementation]

4. Effect of vitamin D3 supplementation on serum creatinine [within 140 day of supplementation]

5. Effect of vitamin D3 supplementation on urinary calcium / creatinine [within 140 day after supplementation]

Secondary Outcome Measures

1. Effect of vitamin D3 supplementation on fasting blood glucose [within 140 day after supplementation]

2. Effect of vitamin D3 supplementation on serum lipids [within 140 day after supplementation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Nutrition Sciences, Chinese Academy of Sciences	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

• Chinese Academy of Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui Wang, Principal Investigator, Chinese Academy of Sciences
• ClinicalTrials.gov Identifier: NCT02158143
• Other Study ID Numbers: CRC-KY1301
• First Posted: Jun 6, 2014
• Last Update Posted: Jun 6, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Vitamin D Deficiency; Vitamin D; Cholecalciferol

Study Results

No Results Posted as of Jun 6, 2014