Vitamin D Intervention Trial in Healthy Chinese
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Vitamin D
- Registration Number
- NCT01817036
- Lead Sponsor
- Chinese Academy of Sciences
- Brief Summary
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;
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Age: 20-45 years. with vitamin D deficiency (25(OH)D < 50 nmol/l)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 5 placebo pills per day, 16 weeks 800 IU Vitamin D (3 placebo pills + 2 vitamin D pills) per day, 16 weeks 1200 IU Vitamin D (2 placebo pills + 3 vitamin D pills) per day, 16 weeks 400 IU Vitamin D (4 placebo pills + 1 vitamin D pill) per day, 16 weeks 1200 IU Placebo (2 placebo pills + 3 vitamin D pills) per day, 16 weeks 400 IU Placebo (4 placebo pills + 1 vitamin D pill) per day, 16 weeks 800 IU Placebo (3 placebo pills + 2 vitamin D pills) per day, 16 weeks 2000 IU Vitamin D 5 vitamin D pills per day, 16 weeks
- Primary Outcome Measures
Name Time Method 25-hydroxyvitamin D 16 weeks Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method
- Secondary Outcome Measures
Name Time Method creatinine 16 weeks creatinine will be measured by an Automatic biochemical analyzer
aspartate aminotransferase(AST) 16 weeks Serum AST will be measured by an Automatic biochemical analyzer;
urea nitrogen 16 weeks Serum urea nitrogen will be measured by an Automatic biochemical analyzer
calcium 16 weeks Serum calcium will be measured by an Automatic biochemical analyzer.
glutamyl transpeptidase（GGT） 16 weeks Serum GGT will be measured by an Automatic biochemical analyzer
uric acid 16 weeks Serum uric acid will be measured by an Automatic biochemical analyzer
parathyroid hormone（PTH） 16 weeks alanine aminotransferase（ALT) 16 weeks Serum ALT will be measured by an Automatic biochemical analyzer
phosphate 16 weeks Serum phosphate will be measured by an Automatic biochemical analyzer.
Trial Locations
- Locations (1)
Institute for Nutritional Sciences, Chinese Academy of Sciences
🇨🇳Shanghai, Shanghai, China