Status:
COMPLETED
Vitamin D Intervention Trial in Healthy Chinese
Lead Sponsor:
Chinese Academy of Sciences
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
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. T...
Eligibility Criteria
Inclusion
- Age: 20-45 years. with vitamin D deficiency (25(OH)D \< 50 nmol/l)
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01817036
Start Date
January 1 2013
End Date
July 1 2013
Last Update
January 18 2016
Active Locations (1)
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1
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, China, 200031