Vitamin D Intervention Trial in Healthy Chinese

Vitamin D Deficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817036
• Other study ID #: KSCX2-EW-R-10-VD
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2013
• Last updated: January 15, 2016
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: January 2016
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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;

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Placebo
placebo
• Vitamin D
400 IU vitamin D per pill

Locations

Country	Name	City	State
China	Institute for Nutritional Sciences, Chinese Academy of Sciences	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D	Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method	16 weeks	Yes
Secondary	alanine aminotransferase(ALT)	Serum ALT will be measured by an Automatic biochemical analyzer	16 weeks	Yes
Secondary	aspartate aminotransferase(AST)	Serum AST will be measured by an Automatic biochemical analyzer;	16 weeks	Yes
Secondary	glutamyl transpeptidase(GGT)	Serum GGT will be measured by an Automatic biochemical analyzer	16 weeks	Yes
Secondary	creatinine	creatinine will be measured by an Automatic biochemical analyzer	16 weeks	Yes
Secondary	uric acid	Serum uric acid will be measured by an Automatic biochemical analyzer	16 weeks	Yes
Secondary	urea nitrogen	Serum urea nitrogen will be measured by an Automatic biochemical analyzer	16 weeks	Yes
Secondary	calcium	Serum calcium will be measured by an Automatic biochemical analyzer.	16 weeks	Yes
Secondary	phosphate	Serum phosphate will be measured by an Automatic biochemical analyzer.	16 weeks	Yes
Secondary	parathyroid hormone(PTH)		16 weeks	Yes