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

NCT ID: NCT02158143

Last Updated: 2014-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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

Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vitamin D3

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Interventions

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vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hui Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Nutrition Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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CRC-KY1301

Identifier Type: -

Identifier Source: org_study_id

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