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Completed

NCT Number: NCT01817036

Vitamin D Intervention Trial in Healthy Chinese

To determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L;

Completed

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute for Nutritional Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, 200031, China

About this study

Recent epidemiological studies suggested that serum 25-hydroxyvitamin D [25(OH)D] concentration ≥75 nmol/L appeared to be optimal for preventing cardiometabolic diseases and improving bone health. To achieve this goal, a daily intake of 1000 IU or equivalent amount from other sources, is needed, which is twice as much as the RDA recommended by Chinese Nutrition Society. Meanwhile,epidemiological evidences show that large proportions of Chinese may suffer vitamin D insufficiency or deficiency whereas the current RDA in China might be too low to provide adequate vitamin D for people's health.

In order to fill up this gap, therefore, it is essential to determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L.Ultimately, the current study will provide important evidence for establishing optimal vitamin D requirement for Chinese people

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 20-45 years. with vitamin D deficiency (25(OH)D < 50 nmol/l)

Exclusion criteria

  • BMI < 18.5 kg/m2, or BMI ≥ 25 kg/m2
  • Total intake of calcium from diet or supplements >1200mg/d, or fasting serum calcium level ≥2.75 mmol/l
  • Participating in other clinical studies within previous 3 months
  • Taking vitamin D supplements within previous 3 months
  • Using medications that may affect vitamin D metabolism in previous 3 months;
  • Concomitant with clinical conditions, like liver dysfunction (serum alanine transaminase (ALT) ≥40 U/L; and/or aspartate transaminase (AST) ≥40 U/L; Glutamyl transpeptidase (GGT)≥50 U/L; serum creatinine < 50 or > 120 µmol/L; urea nitrogen (UN) < 7 or > 18 mg/dl, and/or urine acid <90 or >420 µmol/L; which may affect vitamin D metabolism;
  • History of drug or alcohol abuse (>40 g/d)
  • Women during pregnancy or lactation
  • Individuals with mental disorders or current use of antidepressants, the conditions which may affect him or her understanding and unwillingness to the intervention;
  • Having clinically diagnosed AIDS, hepatitis A, hepatitis B, tuberculosis and other infectious diseases.

Treatment and study plan

Placebo

Dietary Supplement

placebo

Vitamin D

Dietary Supplement

400 IU vitamin D per pill

Primary outcomes

  1. 25-hydroxyvitamin D

    Time frame: 16 weeks

    Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method

Secondary outcomes

  1. alanine aminotransferase(ALT)

    Time frame: 16 weeks

    Serum ALT will be measured by an Automatic biochemical analyzer

  2. aspartate aminotransferase(AST)

    Time frame: 16 weeks

    Serum AST will be measured by an Automatic biochemical analyzer;

  3. glutamyl transpeptidase(GGT)

    Time frame: 16 weeks

    Serum GGT will be measured by an Automatic biochemical analyzer

  4. creatinine

    Time frame: 16 weeks

    creatinine will be measured by an Automatic biochemical analyzer

  5. uric acid

    Time frame: 16 weeks

    Serum uric acid will be measured by an Automatic biochemical analyzer

  6. urea nitrogen

    Time frame: 16 weeks

    Serum urea nitrogen will be measured by an Automatic biochemical analyzer

  7. calcium

    Time frame: 16 weeks

    Serum calcium will be measured by an Automatic biochemical analyzer.

  8. phosphate

    Time frame: 16 weeks

    Serum phosphate will be measured by an Automatic biochemical analyzer.

  9. parathyroid hormone(PTH)

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Registry information

Official study title

Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study:A Pilot Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2013
Registry last updated
Jan 18, 2016

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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