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Vitamin D Intervention Trial in Healthy Chinese

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Placebo
Vitamin D
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D, deficiency, dose response

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute for Nutritional Sciences, Chinese Academy of Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

400 IU

800 IU

1200 IU

2000 IU

Arm Description

5 placebo pills per day, 16 weeks

(4 placebo pills + 1 vitamin D pill) per day, 16 weeks

(3 placebo pills + 2 vitamin D pills) per day, 16 weeks

(2 placebo pills + 3 vitamin D pills) per day, 16 weeks

5 vitamin D pills per day, 16 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

alanine aminotransferase（ALT)
Serum ALT will be measured by an Automatic biochemical analyzer
aspartate aminotransferase(AST)
Serum AST will be measured by an Automatic biochemical analyzer;
glutamyl transpeptidase（GGT）
Serum GGT will be measured by an Automatic biochemical analyzer
creatinine
creatinine will be measured by an Automatic biochemical analyzer
uric acid
Serum uric acid will be measured by an Automatic biochemical analyzer
urea nitrogen
Serum urea nitrogen will be measured by an Automatic biochemical analyzer
calcium
Serum calcium will be measured by an Automatic biochemical analyzer.
phosphate
Serum phosphate will be measured by an Automatic biochemical analyzer.
parathyroid hormone（PTH）

Full Information

First Posted
March 20, 2013
Last Updated
January 15, 2016
Sponsor
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01817036
Brief Title
Vitamin D Intervention Trial in Healthy Chinese
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, deficiency, dose response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 placebo pills per day, 16 weeks
Arm Title
400 IU
Arm Type
Experimental
Arm Description
(4 placebo pills + 1 vitamin D pill) per day, 16 weeks
Arm Title
800 IU
Arm Type
Experimental
Arm Description
(3 placebo pills + 2 vitamin D pills) per day, 16 weeks
Arm Title
1200 IU
Arm Type
Experimental
Arm Description
(2 placebo pills + 3 vitamin D pills) per day, 16 weeks
Arm Title
2000 IU
Arm Type
Experimental
Arm Description
5 vitamin D pills per day, 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
400 IU vitamin D per pill
Primary Outcome Measure Information:
Title
25-hydroxyvitamin D
Description
Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
alanine aminotransferase（ALT)
Description
Serum ALT will be measured by an Automatic biochemical analyzer
Time Frame
16 weeks
Title
aspartate aminotransferase(AST)
Description
Serum AST will be measured by an Automatic biochemical analyzer;
Time Frame
16 weeks
Title
glutamyl transpeptidase（GGT）
Description
Serum GGT will be measured by an Automatic biochemical analyzer
Time Frame
16 weeks
Title
creatinine
Description
creatinine will be measured by an Automatic biochemical analyzer
Time Frame
16 weeks
Title
uric acid
Description
Serum uric acid will be measured by an Automatic biochemical analyzer
Time Frame
16 weeks
Title
urea nitrogen
Description
Serum urea nitrogen will be measured by an Automatic biochemical analyzer
Time Frame
16 weeks
Title
calcium
Description
Serum calcium will be measured by an Automatic biochemical analyzer.
Time Frame
16 weeks
Title
phosphate
Description
Serum phosphate will be measured by an Automatic biochemical analyzer.
Time Frame
16 weeks
Title
parathyroid hormone（PTH）
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Lin, PhD
Organizational Affiliation
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Nutritional Sciences, Chinese Academy of Sciences
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

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Vitamin D Intervention Trial in Healthy Chinese

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