HypertensionDAYLIGHTNCT01240512
DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
A study testing Cholecalciferol in people with Hypertension and Vitamin D Deficiency, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day) versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early stage 1 hypertension and vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Vitamin D Deficiency, Pre-Hypertension
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Oct 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females 18 to 50 years of age
- Systolic blood pressure of 120 to 159 mmHg and Diastolic blood pressure ≤99 mmHg
- Vitamin D deficiency, defined as 25-hydroxyvitamin D <25 ng/ml
- No use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
- No use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
Who cannot join
- Use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
- Use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
- Use of St. John's wart, rifampin, any treatment for HIV, orlistat, oral glucocorticoids, phenobarbital, phenytoin, mineral oil, or bile acid sequestrants in the last 3 months or anticipated or planned use in next 6 months
- Female who is pregnant, nursing, or of childbearing potential and planning or anticipating pregnancy in next 6 months
- History of diabetes mellitus (including Type 1, Type 2 and diet controlled)
- Serum creatinine >2.0 mg/dl or estimated Glomerular Filtration Rate (GFR) <30 ml/min
Show all 19Show fewer
- Calcium >10.0 mg/dl or phosphorus >5 mg/dl
- History of kidney stones
- Body mass index >38 kg/m2
- Known cardiovascular disease: defined as prior myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass or stroke
- History of cirrhosis or severe liver disease (defined as history of GI bleeding from liver disease, jaundice or ascites)
- Current heavy alcohol use: defined as drinking 5 or more drinks per occasion on 5 or more days in the past 30 days
- History of ulcerative colitis, Crohn's disease, celiac disease, colostomy, pancreatic enzyme deficiency, short bowel syndrome, gastric bypass, cystic fibrosis, or dumping syndrome.
- Allergy to coconut
- Regular use or planned use of artificial tanning lights in next 6 months
- Use of any investigational product or device in last 3 months or planned use in next 6 months
- Any condition which could limit the ability to complete and comply with 6-month follow up
- Unwillingness or inability to comply with study requirements
- Inability to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hartford Hospital
Hartford, Connecticut, 06106
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension
This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day) versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be stored for future biomarker assessments. The total duration of the study is anticipated to be 18 months, assuming a 12 month enrollment period.
- Conditions
- Hypertension, Vitamin D Deficiency, Pre-Hypertension
- Being tested
- Cholecalciferol
- Medical subject headings
- Hypertension, Vitamin D Deficiency, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
Vitamin D3 (cholecalciferol) 200 IU and 2000 IU drops will be supplied by D Drops. It is supplied as a liquid containing 400 drops/bottle with a potency of 200 IU/drop or 2000 IU/drop. The contents of the label will be in accordance with all applicable regulatory requirements. The droppers are gravity-metered to deliver a consistent drop size (dosage). Two drops (either 200 IU or 2000 IU) of Vitamin D (cholecalciferol) is to be taken orally once-daily.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Arm | Active comparator | 4000 IU/day Vitamin D3 (cholecalciferol) supplementation Receives: Drug: Cholecalciferol |
| Low Dose Arm | Active comparator | 400 IU/day Vitamin D3 (cholecalciferol) supplementation Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
Measured: 24 hours
Secondary outcomes (5)
Change in mean 24-hour ambulatory diastolic blood pressure
Measured: 24 hours
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
Measured: 24 hours
Change in mean clinic systolic and diastolic blood pressure
Measured: 6 months
Change in mean clinic pulse pressure
Measured: 6 months
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2013
- Study completionOct 2013
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital, Allina Health System
- Responsible party
- Principal investigator, Thomas J. Wang, MD, Massachusetts General Hospital
- Investigators
- Thomas J Wang, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240512
- Sponsor's protocol ID
- 2010P001612
- Acronym
- DAYLIGHT
- Status last verified
- Mar 2017
- First submitted
- 11 Nov 2010
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miao J, Bachmann KN, Huang S, Su YR, Dusek J, Newton-Cheh C, Arora P, Wang TJ. Effects of Vitamin D Supplementation on Cardiovascular and Glycemic Biomarkers. J Am Heart Assoc. 2021 May 18;10(10):e017727. doi: 10.1161/JAHA.120.017727. Epub 2021 May 7.
PubMed 33960201Zaleski A, Panza G, Swales H, Arora P, Newton-Cheh C, Wang T, Thompson PD, Taylor B. High-Dose versus Low-Dose Vitamin D Supplementation and Arterial Stiffness among Individuals with Prehypertension and Vitamin D Deficiency. Dis Markers. 2015;2015:918968. doi: 10.1155/2015/918968. Epub 2015 Sep 16.
PubMed 26451070Arora P, Song Y, Dusek J, Plotnikoff G, Sabatine MS, Cheng S, Valcour A, Swales H, Taylor B, Carney E, Guanaga D, Young JR, Karol C, Torre M, Azzahir A, Strachan SM, O'Neill DC, Wolf M, Harrell F, Newton-Cheh C, Wang TJ. Vitamin D therapy in individuals with prehypertension or hypertension: the DAYLIGHT trial. Circulation. 2015 Jan 20;131(3):254-62. doi: 10.1161/CIRCULATIONAHA.114.011732. Epub 2014 Oct 30.
PubMed 25359163
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension
- ClinicalTrials.gov ID
- NCT01240512
- Acronym / sponsor ID
- DAYLIGHT / 2010P001612
- Conditions
- Hypertension, Vitamin D Deficiency, Pre-Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Hartford Hospital, Allina Health System
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Nov 2010 (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.
This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day) versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be stored for future biomarker assessments. The total duration of the study is anticipated to be 18 months, assuming a 12 month enrollment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Arm | Active comparator | Drug: Cholecalciferol4000 IU/day Vitamin D3 (cholecalciferol) supplementation |
| Low Dose Arm | Active comparator | Drug: Cholecalciferol400 IU/day Vitamin D3 (cholecalciferol) supplementation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females 18 to 50 years of age
- Systolic blood pressure of 120 to 159 mmHg and Diastolic blood pressure ≤99 mmHg
- Vitamin D deficiency, defined as 25-hydroxyvitamin D <25 ng/ml
- No use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
- No use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
Key exclusion criteria (19 listed)
- Use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
- Use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
- Use of St. John's wart, rifampin, any treatment for HIV, orlistat, oral glucocorticoids, phenobarbital, phenytoin, mineral oil, or bile acid sequestrants in the last 3 months or anticipated or planned use in next 6 months
- Female who is pregnant, nursing, or of childbearing potential and planning or anticipating pregnancy in next 6 months
- History of diabetes mellitus (including Type 1, Type 2 and diet controlled)
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D3Vitamin D3 (cholecalciferol) 200 IU and 2000 IU drops will be supplied by D Drops. It is supplied as a liquid containing 400 drops/bottle with a potency of 200 IU/drop or 2000 IU/drop. The contents of the label will be in accordance with all applicable regulatory requirements. The droppers are gravity-metered to deliver a consistent drop size (dosage). Two drops (either 200 IU or 2000 IU) of Vitamin D (cholecalciferol) is to be taken orally once-daily. | Drug | High Dose Arm, Low Dose Arm |
Primary outcome
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
Time frame: 24 hours
5 secondary outcomes
Change in mean 24-hour ambulatory diastolic blood pressure
Time frame: 24 hours
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
Time frame: 24 hours
Change in mean clinic systolic and diastolic blood pressure
Time frame: 6 months
Change in mean clinic pulse pressure
Time frame: 6 months
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
Time frame: 6 months
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 9 Mar 2017.
- Derived from this study: PubMed 33960201Miao J, Bachmann KN, Huang S, Su YR, Dusek J, Newton-Cheh C, Arora P, Wang TJ. Effects of Vitamin D Supplementation on Cardiovascular and Glycemic Biomarkers. J Am Heart Assoc. 2021 May 18;10(10):e017727. doi: 10.1161/JAHA.120.017727. Epub 2021 May 7.
- Derived from this study: PubMed 26451070Zaleski A, Panza G, Swales H, Arora P, Newton-Cheh C, Wang T, Thompson PD, Taylor B. High-Dose versus Low-Dose Vitamin D Supplementation and Arterial Stiffness among Individuals with Prehypertension and Vitamin D Deficiency. Dis Markers. 2015;2015:918968. doi: 10.1155/2015/918968. Epub 2015 Sep 16.
- Derived from this study: PubMed 25359163Arora P, Song Y, Dusek J, Plotnikoff G, Sabatine MS, Cheng S, Valcour A, Swales H, Taylor B, Carney E, Guanaga D, Young JR, Karol C, Torre M, Azzahir A, Strachan SM, O'Neill DC, Wolf M, Harrell F, Newton-Cheh C, Wang TJ. Vitamin D therapy in individuals with prehypertension or hypertension: the DAYLIGHT trial. Circulation. 2015 Jan 20;131(3):254-62. doi: 10.1161/CIRCULATIONAHA.114.011732. Epub 2014 Oct 30.
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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.
Thomas J Wang, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Hypertension and Vitamin D Deficiency, run by Massachusetts General Hospital at 3 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 5 inclusion and 19 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure. (time frame: 24 hours). 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 NCT01240512, 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 9 Mar 2017.