Vitamin D Intervention Trial in Healthy Chinese | NCT01817036

Studies
Vitamin D Intervention Trial in Healthy Chinese

NCT01817036

Sponsor

Chinese Academy of Sciences

Status

Completed

Last Update Posted

Jan 18, 2016Estimated

Enrollment

75Actual

Phase

Phase 1

Conditions

Vitamin D Deficiency

Interventions

Placebo
Vitamin D

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

May 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2016

Last Update Posted Date

Jan 18, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	5 placebo pills per day, 16 weeks	Dietary Supplement: Placebo
400 IU	Experimental	(4 placebo pills + 1 vitamin D pill) per day, 16 weeks	Dietary Supplement: Placebo Dietary Supplement: Vitamin D
800 IU	Experimental	(3 placebo pills + 2 vitamin D pills) per day, 16 weeks	Dietary Supplement: Placebo Dietary Supplement: Vitamin D
1200 IU	Experimental	(2 placebo pills + 3 vitamin D pills) per day, 16 weeks	Dietary Supplement: Placebo Dietary Supplement: Vitamin D
2000 IU	Experimental	5 vitamin D pills per day, 16 weeks	Dietary Supplement: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	placebo	1200 IU 400 IU 800 IU Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
25-hydroxyvitamin D	Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
alanine aminotransferase（ALT)	Serum ALT will be measured by an Automatic biochemical analyzer	16 weeks
aspartate aminotransferase(AST)	Serum AST will be measured by an Automatic biochemical analyzer;

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xu Lin, PhD	Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Nutritional Sciences, Chinese Academy of Sciences		Shanghai	Shanghai Municipality	200031	China

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds