NCT01474486

Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure

Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Phoenix VA Health Care System · Federal
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to conduct a preliminary test of the feasibility of a multi-micronutrient intervention to improve micronutrient status, cardiac function and quality of life in Veterans with Congestive Heart Failure (CHF).

Detailed description

Veterans with stable CHF resulting from ischemic cardiomyopathy with systolic dysfunction and an ejection fraction ≤45% and who fit the criteria of stage B, C and D 2 heart failure will be recruited. This is a one group study with Veterans serving as their own control. They will receive 50 mg thiamin, vitamin B50 and 220 mg Zn as Zn sulfate daily for 6 months. Additionally, they will receive 50,000 IU Vitamin D as ergocalciferol each week for 8 weeks then every other week for 16 weeks. Pre (baseline) and post (6 months) cardiac function will be tested with echocardiogram and cardiac MR (when applicable), biochemical measures of thiamine, pyridoxine, zinc and Vitamin D will be measured at baseline, 3 months, 6 months and one year. Quality of life will be measured using the Minnesota Living with Heart Failure questionnaire baseline, month 3,6,and one year. Nutritional assessment including a nutrition focused physical examination and three days food records will also be measured at baseline, month 3, 6 and one year.

Conditions

• Congestive Heart Failure
• Ischemic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Micronutrients	Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2011-11-18
• Last updated: 2021-06-10
• Results posted: 2021-05-27

Locations

1 site across 1 country: United States