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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02087683
• Date of registration: 12/03/2014
• Prospective Registration: Yes
• Primary sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
• Public title: Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency
• Scientific title: Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency
• Date of first enrolment: November 2014
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02087683
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Leticia Elizondo-Montemayor, MD

• Name: Leticia Elizondo-Montemayor, MD
• Affiliation: Instituto Tecnologico y de Estudios Superiores de Monterey

• Name: Leticia Elizondo-Montemayor, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with heart failure with:

1. Ventricular ejection fraction of <40%

2. B natriuretic peptide > 300 milligrams per milliliter

3. Pharmacologic therapy with angiotensin converting enzyme inhibitors (ACEI) and beta
blockers (BB)

4. NYHA class III or IV

5. Vitamin D insufficiency (less than 30 ng/ml)

Exclusion Criteria:

1. Subjects without hear failure diagnosis

2. Subjects with ventricular ejection fraction above 40%

3. Subjects with BNP <300 mg/ml

4. Subjects who don't take ACEI or BB

5. Subjects with NYHA class I or II

6. Subjects with serum vitamin D of = 30 ng/ml

7. Subjects with metallic implants (due to magnetic resonance)

8. Subjects allergic to contrast media (gadolinium) used for magnetic resonance

9. Subjects with renal failure due to failure to eliminate contrast media

Suspension Criteria:

1. From intervention group: subjects who stop taking the supplement or take a different
dosage than recommended for more than 80% of the time frame

2. Both groups: subjects who stop attending their monthly clinical evaluation with a
cardiologist

3. Subjects who don't show up for their evaluation dates given for anthropometric
measurements and laboratory sample taking

4. Subjects who don't show up their final magnetic resonance evaluation

5. Subjects having adverse symptoms to vitamin D supplementation; those suspected to have
an overdose reaction

6. Subjects having an allergic reaction to magnetic resonance contrast media (gadolinium)
during the magnetic resonance image taking



Age minimum: 45 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Vitamin D Deficiency

Heart Failure

Intervention(s)

Other: Control group (Placebo)

Other: Vitamin D Supplementation

Primary Outcome(s)

Change from baseline in myocardial function and structure at 12 months [Time Frame: 12 months]

Secondary Outcome(s)

Change from baseline in serum calcium 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 inflammatory cytokines 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 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 diastolic blood pressure 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 parathyroid hormone at 12 months [Time Frame: 12 months]

Change from baseline in systolic blood pressure at 12 months [Time Frame: 12 months]

Secondary ID(s)

ESVDIC2013-CINCO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors