Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
This study is currently recruiting participants.
Verified November 2011 by Phoenix VA Health Care System
Sponsor:
Phoenix VA Health Care System
Information provided by (Responsible Party):
Diane Parrington, Phoenix VA Health Care System
ClinicalTrials.gov Identifier:
NCT01474486
First received: January 28, 2011
Last updated: November 17, 2011
Last verified: November 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 28, 2011 | ||||
| Last Updated Date | November 17, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in left ventricular ejection fraction (LVEF) between baseline and six months [ Time Frame: Change in LVEF between baseline and six months ] [ Designated as safety issue: No ] LVEF will be measured using cardiac magnetic resonance imaging and strain echocardiogram |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01474486 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure | ||||
| Official Title ICMJE | Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF) | ||||
| Brief 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). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: 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) |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | January 2013 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 89 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01474486 | ||||
| Other Study ID Numbers ICMJE | Parrington 005 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Diane Parrington, Phoenix VA Health Care System | ||||
| Study Sponsor ICMJE | Phoenix VA Health Care System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Phoenix VA Health Care System | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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