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OpenTrials
Completed

NCT Number: NCT02158143

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.

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Key information

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Nutrition Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

Primary outcomes

  1. Effect of vitamin D3 supplementation on serum 25(OH)D changes

    Time frame: within 140 day after supplementation

  2. Effect of vitamin D3 supplementation on serum PTH

    Time frame: within 140 day after supplementation

  3. Effect of vitamin D3 supplementation on serum calcium

    Time frame: within 140 day after supplementation

  4. Effect of vitamin D3 supplementation on serum creatinine

    Time frame: within 140 day of supplementation

  5. Effect of vitamin D3 supplementation on urinary calcium / creatinine

    Time frame: within 140 day after supplementation

Secondary outcomes

  1. Effect of vitamin D3 supplementation on fasting blood glucose

    Time frame: within 140 day after supplementation

  2. Effect of vitamin D3 supplementation on serum lipids

    Time frame: within 140 day after supplementation

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Jun 6, 2014
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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