HypercholesterolemiaNCT00723385
Effects of Vitamin D on Lipids
A study testing Vitamin D (1000 or 2000 IU/day) in people with Hypercholesterolemia and Vitamin D Deficiency, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Vitamin D Deficiency
- What is being tested?
- Vitamin D (1000 or 2000 IU/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any medically stable person able to swallow pills
- Inadequate vitamin D status at screening visit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Data from previous trials suggest a protective role of vitamin D in cardiovascular disease. A recent meta-analysis of trials with at least 5 years of follow-up of vitamin D supplementation concluded that intake of vitamin D supplements may decrease total mortality, but that the relationship between baseline vitamin D status, dose of vitamin D supplements, and total mortality rates remains to be investigated. An even more recent analysis of vitamin D concentrations found that participants with vitamin D deficiency and hypertension were about twice as likely as people without hypertension and vitamin D deficiency to have a cardiovascular event during the study.
The main hypothesis to be tested is that normalization of vitamin D levels will lower LDL-cholesterol and total cholesterol concentrations in people with inadequate vitamin D concentrations as determined by circulating 25-OH vitamin D. Subhypotheses are that HDL-cholesterol, triglycerides, lipoprotein(a), hs C-reactive protein and Hemoglobin A1c will not be affected, and that cyp3a-metabolized medication levels will decrease with vitamin D replacement.
This is a 12-week randomized double-blind dose titration study of the effects of supplementation with 1000-2000 IU vitamin D on lipid and vitamin D concentrations. Dietary intake of vitamin D will be estimated by dietary recall questionnaire or analysis of three non-consecutive 24-hour dietary intake logs.
- Conditions
- Hypercholesterolemia, Vitamin D Deficiency
- Being tested
- Vitamin D (1000 or 2000 IU/day), Placebo
- Keywords
- cholesterol, LDL-cholesterol, cholecalciferol, lipids, C-reactive protein
- Medical subject headings
- Hypercholesterolemia, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (1000 or 2000 IU/day)Dietary supplement
Also called cholecalciferol
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
PlaceboOther
Administration of placebo for 12 weeks with repeated D measurements
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording Receives: Other: Placebo |
| Vitamin D | Experimental | Vitamin D (1000 or 2000 IU/day) Receives: Dietary Supplement: Vitamin D (1000 or 2000 IU/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
Measured: 12 weeks
Secondary outcomes (2)
Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects
Measured: 12 weeks
Measures of inflammatory markers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Janice B. Schwartz, MD,FACC,FAHA, Principal investigator, Jewish Home, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723385
- Sponsor's protocol ID
- AG0104
- Other IDs
- 5R01AG015982
- Status last verified
- Apr 2015
- First submitted
- 24 Jul 2008
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17846391Wang 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.
PubMed 18180395Kane 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.
PubMed 24030939
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D on Lipids
- ClinicalTrials.gov ID
- NCT00723385
- Acronym / sponsor ID
- AG0104
- Conditions
- Hypercholesterolemia, Vitamin D Deficiency
- Keywords
- cholesterol, LDL-cholesterol, cholecalciferol, lipids, C-reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data from previous trials suggest a protective role of vitamin D in cardiovascular disease. A recent meta-analysis of trials with at least 5 years of follow-up of vitamin D supplementation concluded that intake of vitamin D supplements may decrease total mortality, but that the relationship between baseline vitamin D status, dose of vitamin D supplements, and total mortality rates remains to be investigated. An even more recent analysis of vitamin D concentrations found that participants with vitamin D deficiency and hypertension were about twice as likely as people without hypertension and vitamin D deficiency to have a cardiovascular event during the study.
The main hypothesis to be tested is that normalization of vitamin D levels will lower LDL-cholesterol and total cholesterol concentrations in people with inadequate vitamin D concentrations as determined by circulating 25-OH vitamin D. Subhypotheses are that HDL-cholesterol, triglycerides, lipoprotein(a), hs C-reactive protein and Hemoglobin A1c will not be affected, and that cyp3a-metabolized medication levels will decrease with vitamin D replacement.
This is a 12-week randomized double-blind dose titration study of the effects of supplementation with 1000-2000 IU vitamin D on lipid and vitamin D concentrations. Dietary intake of vitamin D will be estimated by dietary recall questionnaire or analysis of three non-consecutive 24-hour dietary intake logs.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording |
| Vitamin D | Experimental | Dietary Supplement: Vitamin D (1000 or 2000 IU/day)Vitamin D (1000 or 2000 IU/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any medically stable person able to swallow pills
- Inadequate vitamin D status at screening visit
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D (1000 or 2000 IU/day)Also: cholecalciferolDose 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 | Dietary supplement | Vitamin D |
| PlaceboAdministration of placebo for 12 weeks with repeated D measurements | Other | Placebo |
Primary outcome
LDL-cholesterol
Time frame: 12 weeks
2 secondary outcomes
Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects
Time frame: 12 weeks
Measures of inflammatory markers
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Background: PubMed 17846391Autier 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.
- Background: PubMed 18180395Wang 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.
- Results publication: PubMed 24030939Kane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice B. Schwartz, MD,FACC,FAHA principal investigator
Jewish Home, University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (1000 or 2000 IU/day) in people with Hypercholesterolemia and Vitamin D Deficiency, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-cholesterol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723385, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.