Hypovitaminosis DCEDARSNCT01524874
Comparative Effectiveness of Vitamin D and Repletion Strategies
A study testing Vitamin D3 in people with Hypovitaminosis D and Insulin Resistance, run by Bastyr University at 2 sites in United States.
Trial summary
The importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D, Insulin Resistance, Diabetes
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Nov 2011
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Between18-65 years of age; there is an age-related decline in the absorption, transport or liver hydroxylation of orally-consumed VitD (Harris, 1999) therefore adults older than 65 will be excluded. This population is also at greater risk of being on medications with potential medication interactions, e.g. anticoagulants.
- Willingness to perform baseline screening tests: serum 25-OHD, CBC, Comprehensive metabolic chemistry panel (electrolytes, hepatic and renal function tests, lipids, HgA1C, insulin and glucose)
- Screening serum 25-OHD <33ng/ml (82.5 nmol/ml). If >=33ng/ml (82.5 nmol/ml), subjects will participate in the research study as baseline controls for the nested studies of Klotho and TLR-4.
- Ability to read and speak English
- Willingness to be randomized to one of three active treatments for 3 months
Who cannot join
- Subjects who have a serum baseline 25-OHD >=33ng/ml (82.5 nmol/ml) will be excluded once the VitD sufficient baseline control recruitment goal is met
- Subjects who have historical or current use of extra-dietary VitD, other than what is in a multivitamin, for the previous 3 months.
- LFTs: AST>60 U/L; ALT>65 U/L; Alkaline phosphatase >120 U/L. Total bilirubin>1.5 mg/dL
- Serum creatinine>1.4 mg/dL; BUN >25 mg/dL5. Subjects who are pregnant, or could become pregnant, unless they are using regular birth control (OCPs, condoms, IUD).
- Subjects who have established osteoporosis.
- Subjects who have history or symptoms of a parathyroid disorder.
Show all 14Show fewer
- Subjects who have difficulty swallowing pills.
- Subjects who are unwilling to use sunscreen.
- Subjects who have had a past adverse reaction to sunscreen.
- Subjects who are taking medications over the previous 3 months that interfere with the metabolism of VitD (anti-convulsants, anti-coagulants, oral corticosteroids, or barbiturates).
- Subjects with any psychological conditions or substance abuse that may make the subject non- adherent, such as history of bipolar disorder, mania, untreated anxiety or other mood disorder, as determined by the site PI.
- Other severe illness or mental incapacity that, in the opinion of the site PI, would render the potential subject incapable of participating in the study.
- Allergy to sesame oil base
- Heart arrhythmia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lokahi Health Center
Kailua-Kona, Hawaii, 96740
Bastyr University
Kenmore, Washington, 98028
About this study
Official title: A Comparative Effectiveness Trial of High-quality Vitamin D3 Nutritional Supplements to Replete Serum Vitamin D
The importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement is most effective. It has been recognized that to achieve significant effects - serum concentrations >30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend substantially higher doses than were previously thought sufficient. These higher doses can be easily achieved orally. This clinical trial aims to compare absorption of three available forms of this fat-soluble vitamin, due to the potential differences in absorption of different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily available as supplements, yet these have not been systematically compared. This three-arm, randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and after random administration of one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will result in an equivalent increase in serum 25OHD.
Read the detailed description
VitD has numerous hormonal effects, including regulation of Ca2+ and Mg2+, as well as effects on numerous genes, including insulin and androgens. Mounting literature demonstrates associations between VitD insufficiency and cancer, diabetes and heart disease. VitD insufficiency, defined by concentration of serum 25-hydroxycholecalciferol (25-OHD) <33ng/ml (82.5 nmol/ml), is common at all latitudes; the prevalence is estimated at ~35% in "healthy" populations. VitD testing and replacement is gaining popularity in clinical practice. It is not known whether there is a difference in the effect of equivalent doses of emulsified vs. non-emulsified cholecalciferol (VitD3) supplementation, reflected by quantitative changes in serum 25-OHD. However, clinical observations revealed that in an average of 4.4 months, subjects taking 4000 iu daily of the emulsified form of cholecalciferol improved their 25-OHD levels by 6.76 ng/mL more than those taking 5,000 iu daily of the non-emulsified form. The safety of taking 10,000 IU/day has been confirmed. Taking this dose for 12 weeks should cause a robust increase in serum 25-OHD. This study will provide preliminary data comparing three high quality VitD3 supplements, one a powdered capsule, one a chewable tablet, and the other a lipid-emulsified liquid. Future studies will compare the "better" supplement to conventional VitD replacement using VitD2.
- Conditions
- Hypovitaminosis D, Insulin Resistance, Diabetes
- Being tested
- Vitamin D3
- Keywords
- vitamin d, cholecalciferol, nutritional supplements, hypovitaminosis d, klotho, toll like receptor 4
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance, Diabetes Mellitus, Macular Degeneration, Age-Related, 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Calcitriol
10,000 IU per Day for 12 Weeks
Vitamin D3Dietary supplement
Also called Calcitriol
10,000 IU per Day for 12 Weeks
Vitamin D3Dietary supplement
Also called Calcitriol
10,000 IU per Day for 12 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Powder D3 Capsule - 2,000 IU per Cap | Active comparator | Vital Nutrients Receives: Dietary Supplement: Vitamin D3 |
| Chewable D3 Tablet - 2,000 IU per Tab | Active comparator | Integrative Therapeutics Inc. Receives: Dietary Supplement: Vitamin D3 |
| Liquid D3 Drop - 2,000 IU per Drop | Active comparator | Biotics Research Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean serum 25-hydroxycholecalciferol concentration
To compare the change in serum 25-hydroxycholecalciferol (25-OHD) concentration between three forms of supplemental vitamin D3: a lipid-emulsified form administered in a sesame oil base, a non-emulsified chewable tablet, and a non-emulsified form administered as a capsule, following 12 weeks of supplementation (10,000 IU/day) in D3 insufficient patients (baseline 25-OHD <33ng/ml (82.5 nmol/ml)) patients.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Proportion of participants reaching 25-hydroxycholecalciferol concentration >=33ng/ml (82.5 nmol/ml) between groups
To compare the proportion of participants reaching a laboratory "normal" 25-hydroxycholecalciferol concentration >=33ng/ml (82.5 nmol/ml) between D3 supplement groups following 12-weeks of D3 supplementation at 10,000 IU.day
Measured: 12 weeks
Change in mean Klotho protein concentration
To explore the expression of Klotho protein, and analytes associated with VitD homeostasis, comparing VitD sufficient, i.e. 25-OHD >=33ng/ml (82.5 nmol/ml), patients to those who are VitD insufficient, i.e. 25-OHD <33ng/ml, at baseline screenings, and to compare Klotho protein expression in VitD insufficient participants before and after D3 supplementation (10,000 IU/day), stratified by supplement group assignment.
Measured: Baseline and 12 weeks
Change in Toll-like receptor concentration in monocytes
To explore the change in IFN-gamma induced TLR-4 expression in human monocytes (ex-vivo), comparing VitD sufficient, i.e. 25-OHD >=33ng/ml (82.5 nmol/ml), patients to those who are VitD insufficient, i.e. 25-OHD <33ng/ml, at baseline screenings, and to compare the change in IFN-gamma induced TLR-4 expression in human monocytes (ex-vivo) between VitD groups, following 12 weeks of supplementation with one of three forms of VitD3: lipid-emulsified, non-emulsified chewable tablet, and a non-emulsified encapsulated form.
Measured: Baseline and 12 weeks
Change in mean cardiometabolic risk factors
To explore change in mean fasting glucose, hemoglobin A1c, total cholesterol, fasting insulin, HOMA-IR, LDL, HDL-C, and triglycerides will be reported following 12-weeks of D3 supplementation (10,000 IU/day) in healthy humans
Measured: Baseline- 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Action Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Ryan Bradley, ND, MPH, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524874
- Sponsor's protocol ID
- H30-B11
- Acronym
- CEDARS
- Status last verified
- Jan 2012
- First submitted
- 8 Nov 2011
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness Trial of High-quality Vitamin D3 Nutritional Supplements to Replete Serum Vitamin D
- ClinicalTrials.gov ID
- NCT01524874
- Acronym / sponsor ID
- CEDARS / H30-B11
- Conditions
- Hypovitaminosis D, Insulin Resistance, Diabetes
- Keywords
- vitamin d, cholecalciferol, nutritional supplements, hypovitaminosis d, klotho, toll like receptor 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- Diabetes Action Research and Education Foundation
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Feb 2012 (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 importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement is most effective. It has been recognized that to achieve significant effects - serum concentrations >30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend substantially higher doses than were previously thought sufficient. These higher doses can be easily achieved orally. This clinical trial aims to compare absorption of three available forms of this fat-soluble vitamin, due to the potential differences in absorption of different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily available as supplements, yet these have not been systematically compared. This three-arm, randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and after random administration of one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will result in an equivalent increase in serum 25OHD.
Detailed description
VitD has numerous hormonal effects, including regulation of Ca2+ and Mg2+, as well as effects on numerous genes, including insulin and androgens. Mounting literature demonstrates associations between VitD insufficiency and cancer, diabetes and heart disease. VitD insufficiency, defined by concentration of serum 25-hydroxycholecalciferol (25-OHD) <33ng/ml (82.5 nmol/ml), is common at all latitudes; the prevalence is estimated at ~35% in "healthy" populations. VitD testing and replacement is gaining popularity in clinical practice. It is not known whether there is a difference in the effect of equivalent doses of emulsified vs. non-emulsified cholecalciferol (VitD3) supplementation, reflected by quantitative changes in serum 25-OHD. However, clinical observations revealed that in an average of 4.4 months, subjects taking 4000 iu daily of the emulsified form of cholecalciferol improved their 25-OHD levels by 6.76 ng/mL more than those taking 5,000 iu daily of the non-emulsified form. The safety of taking 10,000 IU/day has been confirmed. Taking this dose for 12 weeks should cause a robust increase in serum 25-OHD. This study will provide preliminary data comparing three high quality VitD3 supplements, one a powdered capsule, one a chewable tablet, and the other a lipid-emulsified liquid. Future studies will compare the "better" supplement to conventional VitD replacement using VitD2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Powder D3 Capsule - 2,000 IU per Cap | Active comparator | Dietary Supplement: Vitamin D3Vital Nutrients |
| Chewable D3 Tablet - 2,000 IU per Tab | Active comparator | Dietary Supplement: Vitamin D3Integrative Therapeutics Inc. |
| Liquid D3 Drop - 2,000 IU per Drop | Active comparator | Dietary Supplement: Vitamin D3Biotics Research |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent
- Between18-65 years of age; there is an age-related decline in the absorption, transport or liver hydroxylation of orally-consumed VitD (Harris, 1999) therefore adults older than 65 will be excluded. This population is also at greater risk of being on medications with potential medication interactions, e.g. anticoagulants.
- Willingness to perform baseline screening tests: serum 25-OHD, CBC, Comprehensive metabolic chemistry panel (electrolytes, hepatic and renal function tests, lipids, HgA1C, insulin and glucose)
- Screening serum 25-OHD <33ng/ml (82.5 nmol/ml). If >=33ng/ml (82.5 nmol/ml), subjects will participate in the research study as baseline controls for the nested studies of Klotho and TLR-4.
- Ability to read and speak English
Key exclusion criteria (14 listed)
- Subjects who have a serum baseline 25-OHD >=33ng/ml (82.5 nmol/ml) will be excluded once the VitD sufficient baseline control recruitment goal is met
- Subjects who have historical or current use of extra-dietary VitD, other than what is in a multivitamin, for the previous 3 months.
- LFTs: AST>60 U/L; ALT>65 U/L; Alkaline phosphatase >120 U/L. Total bilirubin>1.5 mg/dL
- Serum creatinine>1.4 mg/dL; BUN >25 mg/dL5. Subjects who are pregnant, or could become pregnant, unless they are using regular birth control (OCPs, condoms, IUD).
- Subjects who have established osteoporosis.
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 D3Also: Calcitriol10,000 IU per Day for 12 Weeks | Dietary supplement | Powder D3 Capsule - 2,000 IU per Cap |
| Vitamin D3Also: Calcitriol10,000 IU per Day for 12 Weeks | Dietary supplement | Chewable D3 Tablet - 2,000 IU per Tab |
| Vitamin D3Also: Calcitriol10,000 IU per Day for 12 Weeks | Dietary supplement | Liquid D3 Drop - 2,000 IU per Drop |
Primary outcome
Change in mean serum 25-hydroxycholecalciferol concentration
Time frame: Baseline and 12 weeks
To compare the change in serum 25-hydroxycholecalciferol (25-OHD) concentration between three forms of supplemental vitamin D3: a lipid-emulsified form administered in a sesame oil base, a non-emulsified chewable tablet, and a non-emulsified form administered as a capsule, following 12 weeks of supplementation (10,000 IU/day) in D3 insufficient patients (baseline 25-OHD <33ng/ml (82.5 nmol/ml)) patients.
4 secondary outcomes
Proportion of participants reaching 25-hydroxycholecalciferol concentration >=33ng/ml (82.5 nmol/ml) between groups
Time frame: 12 weeks
Change in mean Klotho protein concentration
Time frame: Baseline and 12 weeks
Change in Toll-like receptor concentration in monocytes
Time frame: Baseline and 12 weeks
Change in mean cardiometabolic risk factors
Time frame: Baseline- 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 2 Feb 2012.
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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.
Ryan Bradley, ND, MPH principal investigator
Bastyr University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Hypovitaminosis D and Insulin Resistance, run by Bastyr University at 2 sites 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 6 inclusion and 14 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Change in mean serum 25-hydroxycholecalciferol concentration (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2012.