Heart FailureNCT02087683
Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency
A study testing Vitamin D Supplementation in people with Heart Failure and Vitamin D Deficiency, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
Trial summary
The purpose of this study is to determine the effects of vitamin D supplementation in patients with heart failure and vitamin D deficiency on ventricular function, inflammatory cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum parathyroid hormone and calcium. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Heart Failure, Vitamin D Deficiency
- What is being tested?
- Vitamin D Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2014to Dec 2018
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with heart failure with:
- Ventricular ejection fraction of <40%
- B natriuretic peptide > 300 milligrams per milliliter
- Pharmacologic therapy with angiotensin converting enzyme inhibitors (ACEI) and beta blockers (BB)
- NYHA class III or IV
- Vitamin D insufficiency (less than 30 ng/ml)
Who cannot join
- Subjects without hear failure diagnosis
- Subjects with ventricular ejection fraction above 40%
- Subjects with BNP <300 mg/ml
- Subjects who don't take ACEI or BB
- Subjects with NYHA class I or II
- Subjects with serum vitamin D of ≥ 30 ng/ml
Show all 16Show fewer
- Subjects with metallic implants (due to magnetic resonance)
- Subjects allergic to contrast media (gadolinium) used for magnetic resonance
- Subjects with renal failure due to failure to eliminate contrast media
- Suspension Criteria:
- From intervention group: subjects who stop taking the supplement or take a different dosage than recommended for more than 80% of the time frame
- Both groups: subjects who stop attending their monthly clinical evaluation with a cardiologist
- Subjects who don't show up for their evaluation dates given for anthropometric measurements and laboratory sample taking
- Subjects who don't show up their final magnetic resonance evaluation
- Subjects having adverse symptoms to vitamin D supplementation; those suspected to have an overdose reaction
- Subjects having an allergic reaction to magnetic resonance contrast media (gadolinium) during the magnetic resonance image taking
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey
Monterrey, Nuevo León, 64710
Leticia Elizondo-Montemayor, MD, (01)+52 8188882192, lelizond@itesm.mx
Beatriz Astudillo, MD, (01)+52 8188882192, beatriz.astudillor@gmail.com
About this study
The purpose of this study is to determine the effects of vitamin D supplementation in patients with heart failure and vitamin D deficiency on ventricular function, inflammatory cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum parathyroid hormone and calcium.
Read the detailed description
The protocol will be held in three different Hospitals from Monterrey. Those patients with heart failure will be invited to participate; serum vitamin D will be measured, and those with vitamin D deficiency will be participating, once they meet all the inclusion criteria and none of the exclusion criteria, and sign an informed consent.
Patients will be assigned to the intervention group or placebo group according to their characteristics so that both groups are equally balanced in proportion to similar characteristics and number to guarantee homogeneity in both groups at baseline.
The study will have a 12-month time frame for each patient. Patients can be enrolled at different times.
All patients will undergo:
- A baseline measurement of vitamin D concentration in plasma and then every three months (according to season changes) for a total of five measurements.
- Myocardial function and structure measured by magnetic resonance with contrast media at baseline and end of intervention.
- Heart failure clinical follow-up with a 6 minute walk test, arterial pressure and clinical parameters every month.
- A baseline measurement of serum BNP and then every three months (5 in total).
- Serum lipid profile, glucose and insulin measurements at baseline, intermediate and at the end of the intervention.
- Anthropometric measurements (weight, body mass index, waist circumference, body fat percentage) every month.
- A baseline measurement of inflammatory cytokines in serum and then every three months (5 in total).
- Serum PTH and calcium measured at baseline and end of intervention
At the end of the intervention, patients in the control group will receive vitamin D supplementation of 5 000 IU per day for a whole year, so they receive the same benefits as the intervention group.
Definitions:
Heart failure defined as patients with ventricular ejection fraction less than 40 percent, serum B natriuretic peptide >300 milligrams/milliliters.
Vitamin D deficiency defined as serum vitamin D levels below 30 nano-grams per milliliter.
According to the New York Heart Association (NYHA) Classification System:
- NYHA III defined as marked limitation of physical activity
- NYHA IV defined as symptoms occur even at rest; discomfort with any physical activity.
Statistical analysis plan:
Comparison and p-value measured at baseline and end of intervention will be done with paired t-test for means and McNemar test for proportions.
According to the central limit theorem and the big sample size, there will be no need to evaluate normality for the variables; non-parametric rank test with Wilcoxon sign won't be necessary.
For comparison between independent groups, homogeneity of variance will be evaluated using parametric F test for variables with a normal distribution and with non-parametric Levene test for continuous variables with an abnormal distribution, to compare the means through t-test. Mann-Whitney test won't be necessary for the same reasons listed above.
For comparison of proportions between independent groups will be held with the hypothesis test based on the statistic Z-test, and Fisher test for small samples.
The relation between variables measured in the study with our variable serum vitamin D level, will be done through Pearson's correlation coefficient and a multiple linear regression. That regression will be evaluated through parametric and non-parametric tests with diagnosis of autocorrelation, homoscedasticity and multicollinearity. Regression analysis will be done every time a vitamin D measurement is done (5 in total)
All results will use a significance level of 0.05, equivalent to possibility of type 1 error.
Minitab version 16 software (Minitab Inc, State College, Pennsylvania, USA) will be used for statistical analysis, and Microsoft Excel 2007 (Microsoft Corp., Redmond, Washington, USA) will be used to incorporate the input of date.
- Conditions
- Heart Failure, Vitamin D Deficiency
- Being tested
- Vitamin D Supplementation, Control group (Placebo)
- Keywords
- heart failure, vitamin D deficiency, ventricular function, cytokines
- Medical subject headings
- Heart Failure, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D SupplementationOther
Participants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months. Each patient will attend their respective clinic for clinical evaluation by their cardiologist, whom will give them the vitamin supply for a month.
Control group (Placebo)Other
Participants in this group will receive a placebo made of gelatin and corn oil per day for 12 months. Each patient will attend their respective clinic for clinical evaluation by their cardiologists, whom will give the vitamin supply for a month.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Supplementation | Other | Participants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months. Receives: Other: Vitamin D Supplementation |
| Control Group (Placebo) | Placebo comparator | Participants in this group will receive a placebo containing gelatin and corn oil per day for 12 months Receives: Other: Control group (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in myocardial function and structure at 12 months
Myocardial structure and function will be evaluated using magnetic resonance imaging technique. Statistical results for each variable will be reported as a mean ± standard deviation.
Measured: 12 months
Secondary outcomes (11)
Change from baseline in inflammatory cytokines at 12 months
Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in serum lipid profile at 12 months
Serum lipid profile consisting of total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in serum calcium at 12 months
Serum calcium results will be given in milligrams per deciliter. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in serum parathyroid hormone at 12 months
Parathyroid hormone results will be given in picograms per milliliter. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in serum glucose at 12 months
Serum glucose results will be given in milligrams per deciliter. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in serum insulin at 12 months
Serum insulin results will be given in micro-units per milliliter. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in 6-minute walk test at 12 months
Measured: 12 months
Change from baseline in serum vitamin D level at 12 months
Laboratory results of serum vitamin D will be given in nano-grams per milliliter. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in serum natriuretic peptide at 12 months
Laboratory results of serum B natriuretic peptide will be given in picograms per milliliter. Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in systolic blood pressure at 12 months
Arterial blood pressure measured using sphygmomanometer (Welch Allyn, Inc., Skaneateles Falls New York, USA) in accordance with the American Heart Association technique. Measurements will be given in millimeters of mercury (mmHg). Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Change from baseline in diastolic blood pressure at 12 months
Arterial blood pressure measured using sphygmomanometer (Welch Allyn, Inc., Skaneateles Falls New York, USA) in accordance with the American Heart Association technique. Measurements will be given in millimeters of mercury (mmHg). Statistical results will be reported as a mean ± standard deviation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Leticia Elizondo-Montemayor, MD, Principal investigator, Instituto Tecnologico y de Estudios Superiores de Monterey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087683
- Sponsor's protocol ID
- ESVDIC2013-CINCO
- Status last verified
- Sep 2017
- First submitted
- 12 Mar 2014
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
DeLuca HF. Overview of general physiologic features and functions of vitamin D. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1689S-96S. doi: 10.1093/ajcn/80.6.1689S.
PubMed 15585789Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.
PubMed 22586483Kota SK, Kota SK, Jammula S, Meher LK, Panda S, Tripathy PR, Modi KD. Renin-angiotensin system activity in vitamin D deficient, obese individuals with hypertension: An urban Indian study. Indian J Endocrinol Metab. 2011 Oct;15 Suppl 4(Suppl4):S395-401. doi: 10.4103/2230-8210.86985.
PubMed 22145146Liu LC, Voors AA, van Veldhuisen DJ, van der Veer E, Belonje AM, Szymanski MK, Sillje HH, van Gilst WH, Jaarsma T, de Boer RA. Vitamin D status and outcomes in heart failure patients. Eur J Heart Fail. 2011 Jun;13(6):619-25. doi: 10.1093/eurjhf/hfr032. Epub 2011 May 4.
PubMed 21543375Looker AC, Dawson-Hughes B, Calvo MS, Gunter EW, Sahyoun NR. Serum 25-hydroxyvitamin D status of adolescents and adults in two seasonal subpopulations from NHANES III. Bone. 2002 May;30(5):771-7. doi: 10.1016/s8756-3282(02)00692-0.
PubMed 11996918Milovanovic M, Pesic G, Nikolic V, Jevtovic-Stoimenov T, Vasic K, Jovic Z, Deljanin-Ilic M, Pesic S. Vitamin D deficiency is associated with increased IL-17 and TNFalpha levels in patients with chronic heart failure. Arq Bras Cardiol. 2012 Mar;98(3):259-65. doi: 10.1590/s0066-782x2012005000019. Epub 2012 Feb 29. English, Portuguese, Spanish.
PubMed 22370611Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R. Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving. Am J Clin Nutr. 2009 Apr;89(4):1132-7. doi: 10.3945/ajcn.2008.26890. Epub 2009 Feb 25.
PubMed 19244376Rauchhaus M, Doehner W, Francis DP, Davos C, Kemp M, Liebenthal C, Niebauer J, Hooper J, Volk HD, Coats AJ, Anker SD. Plasma cytokine parameters and mortality in patients with chronic heart failure. Circulation. 2000 Dec 19;102(25):3060-7. doi: 10.1161/01.cir.102.25.3060.
PubMed 11120695Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, Koerfer R. Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2006 Apr;83(4):754-9. doi: 10.1093/ajcn/83.4.754.
PubMed 16600924Vacek JL, Vanga SR, Good M, Lai SM, Lakkireddy D, Howard PA. Vitamin D deficiency and supplementation and relation to cardiovascular health. Am J Cardiol. 2012 Feb 1;109(3):359-63. doi: 10.1016/j.amjcard.2011.09.020. Epub 2011 Nov 8.
PubMed 22071212Witham MD, Crighton LJ, Gillespie ND, Struthers AD, McMurdo ME. The effects of vitamin D supplementation on physical function and quality of life in older patients with heart failure: a randomized controlled trial. Circ Heart Fail. 2010 Mar;3(2):195-201. doi: 10.1161/CIRCHEARTFAILURE.109.907899. Epub 2010 Jan 26.
PubMed 20103775Zia AA, Komolafe BO, Moten M, Ahokas RA, McGee JE, William Rosenberg E, Bhattacharya SK, Weber KT. Supplemental vitamin D and calcium in the management of African Americans with heart failure having hypovitaminosis D. Am J Med Sci. 2011 Feb;341(2):113-8. doi: 10.1097/MAJ.0b013e3182058864.
PubMed 21239963Zittermann A, Dembinski J, Stehle P. Low vitamin D status is associated with low cord blood levels of the immunosuppressive cytokine interleukin-10. Pediatr Allergy Immunol. 2004 Jun;15(3):242-6. doi: 10.1111/j.1399-3038.2004.00140.x.
PubMed 15209957Goel RK, Lal H. Role of vitamin d supplementation in hypertension. Indian J Clin Biochem. 2011 Jan;26(1):88-90. doi: 10.1007/s12291-010-0092-0. Epub 2010 Dec 29.
PubMed 22211023
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT02087683
- Acronym / sponsor ID
- ESVDIC2013-CINCO
- Conditions
- Heart Failure, Vitamin D Deficiency
- Keywords
- heart failure, vitamin D deficiency, ventricular function, cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Mar 2014 (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 determine the effects of vitamin D supplementation in patients with heart failure and vitamin D deficiency on ventricular function, inflammatory cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum parathyroid hormone and calcium.
Detailed description
The protocol will be held in three different Hospitals from Monterrey. Those patients with heart failure will be invited to participate; serum vitamin D will be measured, and those with vitamin D deficiency will be participating, once they meet all the inclusion criteria and none of the exclusion criteria, and sign an informed consent.
Patients will be assigned to the intervention group or placebo group according to their characteristics so that both groups are equally balanced in proportion to similar characteristics and number to guarantee homogeneity in both groups at baseline.
The study will have a 12-month time frame for each patient. Patients can be enrolled at different times.
All patients will undergo:
- A baseline measurement of vitamin D concentration in plasma and then every three months (according to season changes) for a total of five measurements.
- Myocardial function and structure measured by magnetic resonance with contrast media at baseline and end of intervention.
- Heart failure clinical follow-up with a 6 minute walk test, arterial pressure and clinical parameters every month.
- A baseline measurement of serum BNP and then every three months (5 in total).
- Serum lipid profile, glucose and insulin measurements at baseline, intermediate and at the end of the intervention.
- Anthropometric measurements (weight, body mass index, waist circumference, body fat percentage) every month.
- A baseline measurement of inflammatory cytokines in serum and then every three months (5 in total).
- Serum PTH and calcium measured at baseline and end of intervention
At the end of the intervention, patients in the control group will receive vitamin D supplementation of 5 000 IU per day for a whole year, so they receive the same benefits as the intervention group.
Definitions:
Heart failure defined as patients with ventricular ejection fraction less than 40 percent, serum B natriuretic peptide >300 milligrams/milliliters.
Vitamin D deficiency defined as serum vitamin D levels below 30 nano-grams per milliliter.
According to the New York Heart Association (NYHA) Classification System:
- NYHA III defined as marked limitation of physical activity
- NYHA IV defined as symptoms occur even at rest; discomfort with any physical activity.
Statistical analysis plan:
Comparison and p-value measured at baseline and end of intervention will be done with paired t-test for means and McNemar test for proportions.
According to the central limit theorem and the big sample size, there will be no need to evaluate normality for the variables; non-parametric rank test with Wilcoxon sign won't be necessary.
For comparison between independent groups, homogeneity of variance will be evaluated using parametric F test for variables with a normal distribution and with non-parametric Levene test for continuous variables with an abnormal distribution, to compare the means through t-test. Mann-Whitney test won't be necessary for the same reasons listed above.
For comparison of proportions between independent groups will be held with the hypothesis test based on the statistic Z-test, and Fisher test for small samples.
The relation between variables measured in the study with our variable serum vitamin D level, will be done through Pearson's correlation coefficient and a multiple linear regression. That regression will be evaluated through parametric and non-parametric tests with diagnosis of autocorrelation, homoscedasticity and multicollinearity. Regression analysis will be done every time a vitamin D measurement is done (5 in total)
All results will use a significance level of 0.05, equivalent to possibility of type 1 error.
Minitab version 16 software (Minitab Inc, State College, Pennsylvania, USA) will be used for statistical analysis, and Microsoft Excel 2007 (Microsoft Corp., Redmond, Washington, USA) will be used to incorporate the input of date.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplementation | Other | Other: Vitamin D SupplementationParticipants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months. |
| Control Group (Placebo) | Placebo comparator | Other: Control group (Placebo)Participants in this group will receive a placebo containing gelatin and corn oil per day for 12 months |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ventricular ejection fraction of <40%
- B natriuretic peptide > 300 milligrams per milliliter
- Pharmacologic therapy with angiotensin converting enzyme inhibitors (ACEI) and beta blockers (BB)
- NYHA class III or IV
- Vitamin D insufficiency (less than 30 ng/ml)
Key exclusion criteria (16 listed)
- Subjects without hear failure diagnosis
- Subjects with ventricular ejection fraction above 40%
- Subjects with BNP <300 mg/ml
- Subjects who don't take ACEI or BB
- Subjects with NYHA class I or II
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 SupplementationParticipants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months. Each patient will attend their respective clinic for clinical evaluation by their cardiologist, whom will give them the vitamin supply for a month. | Other | Vitamin D Supplementation |
| Control group (Placebo)Participants in this group will receive a placebo made of gelatin and corn oil per day for 12 months. Each patient will attend their respective clinic for clinical evaluation by their cardiologists, whom will give the vitamin supply for a month. | Other | Control Group (Placebo) |
Primary outcome
Change from baseline in myocardial function and structure at 12 months
Time frame: 12 months
Myocardial structure and function will be evaluated using magnetic resonance imaging technique. Statistical results for each variable will be reported as a mean ± standard deviation.
11 secondary outcomes
Change from baseline in inflammatory cytokines at 12 months
Time frame: 12 months
Change from baseline in serum lipid profile at 12 months
Time frame: 12 months
Change from baseline in serum calcium at 12 months
Time frame: 12 months
Change from baseline in serum parathyroid hormone at 12 months
Time frame: 12 months
Change from baseline in serum glucose at 12 months
Time frame: 12 months
Change from baseline in serum insulin at 12 months
Time frame: 12 months
Change from baseline in 6-minute walk test at 12 months
Time frame: 12 months
Change from baseline in serum vitamin D level at 12 months
Time frame: 12 months
Change from baseline in serum natriuretic peptide at 12 months
Time frame: 12 months
Change from baseline in systolic blood pressure at 12 months
Time frame: 12 months
Change from baseline in diastolic blood pressure at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Background: PubMed 15585789DeLuca HF. Overview of general physiologic features and functions of vitamin D. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1689S-96S. doi: 10.1093/ajcn/80.6.1689S.
- Background: PubMed 22586483Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.
- Background: PubMed 22145146Kota SK, Kota SK, Jammula S, Meher LK, Panda S, Tripathy PR, Modi KD. Renin-angiotensin system activity in vitamin D deficient, obese individuals with hypertension: An urban Indian study. Indian J Endocrinol Metab. 2011 Oct;15 Suppl 4(Suppl4):S395-401. doi: 10.4103/2230-8210.86985.
- Background: PubMed 21543375Liu LC, Voors AA, van Veldhuisen DJ, van der Veer E, Belonje AM, Szymanski MK, Sillje HH, van Gilst WH, Jaarsma T, de Boer RA. Vitamin D status and outcomes in heart failure patients. Eur J Heart Fail. 2011 Jun;13(6):619-25. doi: 10.1093/eurjhf/hfr032. Epub 2011 May 4.
- Background: PubMed 11996918Looker AC, Dawson-Hughes B, Calvo MS, Gunter EW, Sahyoun NR. Serum 25-hydroxyvitamin D status of adolescents and adults in two seasonal subpopulations from NHANES III. Bone. 2002 May;30(5):771-7. doi: 10.1016/s8756-3282(02)00692-0.
- Background: PubMed 22370611Milovanovic M, Pesic G, Nikolic V, Jevtovic-Stoimenov T, Vasic K, Jovic Z, Deljanin-Ilic M, Pesic S. Vitamin D deficiency is associated with increased IL-17 and TNFalpha levels in patients with chronic heart failure. Arq Bras Cardiol. 2012 Mar;98(3):259-65. doi: 10.1590/s0066-782x2012005000019. Epub 2012 Feb 29. English, Portuguese, Spanish.
- Background: PubMed 19244376Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R. Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving. Am J Clin Nutr. 2009 Apr;89(4):1132-7. doi: 10.3945/ajcn.2008.26890. Epub 2009 Feb 25.
- Background: PubMed 11120695Rauchhaus M, Doehner W, Francis DP, Davos C, Kemp M, Liebenthal C, Niebauer J, Hooper J, Volk HD, Coats AJ, Anker SD. Plasma cytokine parameters and mortality in patients with chronic heart failure. Circulation. 2000 Dec 19;102(25):3060-7. doi: 10.1161/01.cir.102.25.3060.
- Background: PubMed 16600924Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, Koerfer R. Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2006 Apr;83(4):754-9. doi: 10.1093/ajcn/83.4.754.
- Background: PubMed 22071212Vacek JL, Vanga SR, Good M, Lai SM, Lakkireddy D, Howard PA. Vitamin D deficiency and supplementation and relation to cardiovascular health. Am J Cardiol. 2012 Feb 1;109(3):359-63. doi: 10.1016/j.amjcard.2011.09.020. Epub 2011 Nov 8.
- Background: PubMed 20103775Witham MD, Crighton LJ, Gillespie ND, Struthers AD, McMurdo ME. The effects of vitamin D supplementation on physical function and quality of life in older patients with heart failure: a randomized controlled trial. Circ Heart Fail. 2010 Mar;3(2):195-201. doi: 10.1161/CIRCHEARTFAILURE.109.907899. Epub 2010 Jan 26.
- Background: PubMed 21239963Zia AA, Komolafe BO, Moten M, Ahokas RA, McGee JE, William Rosenberg E, Bhattacharya SK, Weber KT. Supplemental vitamin D and calcium in the management of African Americans with heart failure having hypovitaminosis D. Am J Med Sci. 2011 Feb;341(2):113-8. doi: 10.1097/MAJ.0b013e3182058864.
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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.
Leticia Elizondo-Montemayor, MD principal investigator
Instituto Tecnologico y de Estudios Superiores de Monterey
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 Supplementation in people with Heart Failure and Vitamin D Deficiency, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
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 16 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leticia Elizondo-Montemayor, MD ((01)+52 8188882192, lelizond@itesm.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in myocardial function and structure at 12 months (time frame: 12 months). 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 NCT02087683, which also lists 14 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 14 Sep 2017.