Vitamin D Deficiency
Conditions
Keywords
vitamin D, deficiency, dose response
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
Interventions
DIETARY_SUPPLEMENTPlacebo
placebo
DIETARY_SUPPLEMENTVitamin D
400 IU vitamin D per pill
Sponsors
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 25-hydroxyvitamin D | 16 weeks | Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| aspartate aminotransferase(AST) | 16 weeks | Serum AST will be measured by an Automatic biochemical analyzer; |
| glutamyl transpeptidase（GGT） | 16 weeks | Serum GGT will be measured by an Automatic biochemical analyzer |
| creatinine | 16 weeks | creatinine will be measured by an Automatic biochemical analyzer |
| uric acid | 16 weeks | Serum uric acid will be measured by an Automatic biochemical analyzer |
| alanine aminotransferase（ALT) | 16 weeks | Serum ALT will be measured by an Automatic biochemical analyzer |
| calcium | 16 weeks | Serum calcium will be measured by an Automatic biochemical analyzer. |
| phosphate | 16 weeks | Serum phosphate will be measured by an Automatic biochemical analyzer. |
| parathyroid hormone（PTH） | 16 weeks | — |
| urea nitrogen | 16 weeks | Serum urea nitrogen will be measured by an Automatic biochemical analyzer |
Countries
China
Outcome results
None listed