NCT01817036

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;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

March 20, 2013

Last Update Submit

January 15, 2016

Conditions

Vitamin D Deficiency

Keywords

vitamin Ddeficiencydose response

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • alanine aminotransferase（ALT)

    16 weeks

  • aspartate aminotransferase(AST)

    16 weeks

  • glutamyl transpeptidase（GGT）

    16 weeks

  • creatinine

    16 weeks

  • uric acid

    16 weeks

  • +4 more secondary outcomes

Study Arms (5)

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: PlaceboDietary Supplement: Vitamin D

800 IU

EXPERIMENTAL

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

Dietary Supplement: PlaceboDietary Supplement: Vitamin D

1200 IU

EXPERIMENTAL

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

Dietary Supplement: PlaceboDietary Supplement: Vitamin D

2000 IU

EXPERIMENTAL

5 vitamin D pills per day, 16 weeks

Dietary Supplement: Vitamin D

Interventions

PlaceboDIETARY_SUPPLEMENT

placebo

1200 IU400 IU800 IUPlacebo
Vitamin DDIETARY_SUPPLEMENT

400 IU vitamin D per pill

1200 IU2000 IU400 IU800 IU

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-45 years. with vitamin D deficiency (25(OH)D \< 50 nmol/l)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xu Lin, PhD

    Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

CN(1)