NCT00723385

Brief Summary

The purpose of this study is to examine whether oral vitamin D supplementation in people with inadequate vitamin D concentrations will lower LDL-cholesterol and total cholesterol concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

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

July 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

July 24, 2008

Last Update Submit

April 7, 2015

Conditions

HypercholesterolemiaVitamin D Deficiency

Keywords

cholesterolLDL-cholesterolcholecalciferollipidsC-reactive protein

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol

    12 weeks

Secondary Outcomes (2)

  • Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects

    12 weeks

  • Measures of inflammatory markers

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording

Other: Placebo

Vitamin D

EXPERIMENTAL

Vitamin D (1000 or 2000 IU/day)

Dietary Supplement: Vitamin D (1000 or 2000 IU/day)

Interventions

Vitamin D (1000 or 2000 IU/day)DIETARY_SUPPLEMENT

Dose titration beginning with 1000 IU/day and either remaining at 1000 IU/day for weeks 7-12 if normalized D levels at 6 weeks or increasing to 2000 IU/day for weeks 7-12 if levels not normalized at week 6

Also known as: cholecalciferol
Vitamin D
PlaceboOTHER

Administration of placebo for 12 weeks with repeated D measurements

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any medically stable person able to swallow pills
  • Inadequate vitamin D status at screening visit

You may not qualify if:

  • Clinical instability of underlying disease process (e.g., recent hospitalization, change of dosages of medications within the prior two weeks, or new medications within one month)
  • Recent transfusion
  • Severe renal failure or dialysis
  • Hypercalcemia
  • Malignancy under active treatment
  • Feeding tube
  • Intestinal bypass surgery
  • Inability to swallow tablets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish Home

San Francisco, California, 94112, United States

Location

Related Publications (3)

  • Autier P, Gandini S. Vitamin D supplementation and total mortality: a meta-analysis of randomized controlled trials. Arch Intern Med. 2007 Sep 10;167(16):1730-7. doi: 10.1001/archinte.167.16.1730.

    PMID: 17846391BACKGROUND

  • Wang TJ, Pencina MJ, Booth SL, Jacques PF, Ingelsson E, Lanier K, Benjamin EJ, D'Agostino RB, Wolf M, Vasan RS. Vitamin D deficiency and risk of cardiovascular disease. Circulation. 2008 Jan 29;117(4):503-11. doi: 10.1161/CIRCULATIONAHA.107.706127. Epub 2008 Jan 7.

    PMID: 18180395BACKGROUND

  • Kane L, Moore K, Lutjohann D, Bikle D, Schwartz JB. Vitamin D3 effects on lipids differ in statin and non-statin-treated humans: superiority of free 25-OH D levels in detecting relationships. J Clin Endocrinol Metab. 2013 Nov;98(11):4400-9. doi: 10.1210/jc.2013-1922. Epub 2013 Sep 12.

    PMID: 24030939RESULT

MeSH Terms

Conditions

HypercholesterolemiaVitamin D Deficiency

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Janice B. Schwartz, MD,FACC,FAHA

    Jewish Home, University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

US(1)