Dr. Bradley Berry, Heidi Moretti, MS, RD, and Vince Colucci, RPH, of Saint Patrick Hospital are conducting a randomized controlled trial and have ran out of funding to complete it. In this guest blog, Heidi explains her trial and why she needs your help.
Researchers at the International Heart Institute of Montana (IHI), in combination with Saint Patrick Hospital, are trying to determine if supplemental vitamin D in heart failure patients will improve heart function and quality of life, as well as markers of health outcomes. This is a new and exciting area of research, as observational studies show that patients with heart failure and vitamin D deficiency have an almost 3 fold associated risk of death compared with those who are vitamin D replete, and associated risk of sudden cardiac death is 5 times greater among those with deficiency (Pilz).
Our study is the first to look at high dose vitamin D supplementation and outcomes in patients with vitamin D deficiency and heart failure. Other trials have looked at vitamin D supplementation, but have yet to achieve a blood level of 25OHD greater than 40 ng/ml.
Our research study is trying to determine if vitamin D supplements improve heart failure symptoms, laboratory parameters, cardiopulmonary function, and quality of life (QOL) in vitamin D deficient patients (defined as 25OHD levels < 32 ng/ml).
We currently have 16 patients that have completed the study and have several more patients currently enrolled. We are hopeful that recruiting more patients will show promising results.
We are trying to raise money to complete the last 25% of enrollment to reach a total of 40 patients.
Heart failure results in diminished quality of life, in part due to frailty and muscle weakness. Vitamin D likely plays a role in maintenance of lean body mass and strength (Stewart, Bischoff-Ferrari). Moreover, vitamin D may be a simple, safe adjunct treatment for heart failure that effectively reduces healthcare costs and improves quality of life.
Vitamin D is directly involved in the calcium-related contractility in the heart. Cardiomyocytes and vascular smooth muscle cells have vitamin D receptors (VDR) and calcitriol-dependent calcium binding proteins (Thomasset, DeBoland). The presence of both VDR and calcitriol-dependent calcium binding proteins in these tissues underscores the importance of vitamin D, allowing for onsite conversion of vitamin D precursors to calcitriol and calcium-dependent cellular processes.
Several case reports in children indicate that cardiomyopathy may be induced by vitamin D deficiency with hypocalcemia. Upon repletion of vitamin D, myocardial functioning and calcium levels return to normal in these children (Amirlak, Kim BG, Brown J). Cardiomyopathy due to vitamin D deficiency is likely under diagnosed, and reduced serum calcium levels of heart failure patients may in fact be a consequence of vitamin D deficiency (Zittermann). With the high prevalence of vitamin D deficiency in heart failure patients, therapeutic trials of vitamin D are needed.
Current research hypothesis
We are seeking to determine if supplemental vitamin D3 at a dose of 10,000 IU per day for 6 months will improve quality of life, B type natriuretic peptide (BNP is a hormone that is secreted by the heart ventricles, and high concentrations occur in chronic heart failure), cardiopulmonary exercise testing (a highly sensitive marker of heart failure outcomes), parathyroid hormone [PTH is now considered an independent predictor of cardiovascular disease and mortality (Anderson)].
So far, 16 patients have completed the 6 month trial at the IHI, and we have promising results. We hope to enroll a total of 40 patients, with expectations of continuing this project into a larger scale trial. Our interim analysis shows that supplemental vitamin D3 at 10,000 IU per day improves 25OHD concentrations significantly and is safe. Other findings so far include improvement in functional outcomes and laboratory parameters, as well as quality of life of heart failure patients. This may ultimately reduce their medical costs and health burdens.
Help us continue this research
While we have found some initial exciting results, we have ran out of funding to complete our study. We need your help! We need to raise $4,350 by March 1st. With your help, we can complete our study, publish our findings and influence the care of chronic heart failure for the better.
Heart failure affects 6 million people in the United States. They need your help! Donate today:
If you have any questions please contact us:
- Heidi Moretti, MS, RD at 406-546-9481, or
- Vince Colucci, RPH at 406-544-3565, or
- Dr. Bradley Berry at 406-370-0303
We thank you for your support!