Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency

NCT02087683 | Unknown

• 1 other identifier: ESVDIC2013-CINCO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Vitamin D Deficiency

Keywords

heart failure; vitamin D deficiency; ventricular function; cytokines

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (11)

• Change from baseline in inflammatory cytokines at 12 months

  12 months

• Change from baseline in serum lipid profile at 12 months

  12 months

• Change from baseline in serum calcium at 12 months

  12 months

• Change from baseline in serum parathyroid hormone at 12 months

  12 months

• Change from baseline in serum glucose at 12 months

  12 months

Study Arms (2)

Vitamin D Supplementation

OTHER

Participants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months.

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

Other: Control group (Placebo)

Interventions

Vitamin D Supplementation OTHER

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.

Vitamin D Supplementation

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.

Control Group (Placebo)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey

Monterrey, Nuevo León, 64710, Mexico

RECRUITING

Related Publications (14)

• 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.

  PMID: 15585789 BACKGROUND

• Gepner 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.

  PMID: 22586483 BACKGROUND

• Kota 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.

  PMID: 22145146 BACKGROUND

• Liu 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.

  PMID: 21543375 BACKGROUND

• Looker 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.

  PMID: 11996918 BACKGROUND

• Milovanovic 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.

  PMID: 22370611 BACKGROUND

• Mocanu 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.

  PMID: 19244376 BACKGROUND

• Rauchhaus 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.

  PMID: 11120695 BACKGROUND

• Schleithoff 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.

  PMID: 16600924 BACKGROUND

• Vacek 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.

  PMID: 22071212 BACKGROUND

• Witham 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.

  PMID: 20103775 BACKGROUND

• Zia 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.

  PMID: 21239963 BACKGROUND

• Zittermann 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.

  PMID: 15209957 BACKGROUND

• Goel 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.

  PMID: 22211023 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Vitamin D Deficiency

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Leticia Elizondo-Montemayor, MD

  Instituto Tecnologico y de Estudios Superiores de Monterey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leticia Elizondo-Montemayor, MD

CONTACT

(01)+52 8188882192; lelizond@itesm.mx

Beatriz Astudillo, MD

CONTACT

(01)+528188882191; beatriz.astudillor@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences. TEC Salud. Tecnológico de Monterrey

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

ME (1)