A study to Evaluate PPI s effect on vitamin D levels. Rani Hanna M.D., M.S. PGY-3 Joseph Grisanti, MD
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1 A study to Evaluate PPI s effect on vitamin D levels Rani Hanna M.D., M.S. PGY-3 Joseph Grisanti, MD
2 The sunshine vitamin Existed over 500 million years. Prehormone, not only a vitamin. Two major sources: Human skin due to sun light exposure Food, supplement ingestion Fat soluble. Absorbed in the small intestine along with dietary fat.
3 Vitamin D deficiency Rickets. Muscle weakness and fall. Osteoporosis and fractures. Cancer. HTN and LVH. DM. Increased risk preeclampsia. The overall prevalence rate of vitamin D deficiency is 41.6%. Holick MF. N Engl J Med. 2007;357:
4 Proton pump inhibitors Progressively increased use over the past 25 years million prescription $7.2 billion in US sales PPI overutilization. 80% of PPIs in the US are purchased without either a prescription or physician evaluation of GERD. Drug Topics, 2012a, 2012b Heidelbaugh, et al. The American journal of gastroenterology, 104, S27-S32.
5 PPI side effects Enteric infections including C diff associated diarrhea. Pneumonia. Altered antiplatelet metabolism (e.g. Clopidogrel). Osteoporosis related fractures. Deshpande, et al. Clinical Gastroenterology 10.3 (2012): Sarkar, Monika, et al. Annals of Internal Medicine149.6 (2008): Pezalla,et al. (2008).journal of American College of Cardiology, 52,
6 Side effect cont. Vitamins and minerals deficiencies. Vitamin B12 Vitamin C Calcium Iron Magnesium Howden, Colin W. Journal of clinical gastroenterology 30.1 (2000): McColl, K.,"The American journal of gastroenterology 104 (2009): S5-S9 Insogna, Karl L." The American journal of gastroenterology 104 (2009): S2-S4.. Sharma, et al."southern medical journal 97.9 (2004): Cundy, Tim, Mackay. " Current opinion in gastroenterology 27.2 (2011):
7 Purpose of study To evaluate the effect of proton pump inhibitors on vitamin D levels in patients who are treated for vitamin D deficiency or insufficiency.
8 Study Design Institutional Review Board (IRB) approval through Mercy Hospital of Buffalo. Study was conducted at Buffalo Rheumatology clinic in Buffalo. Subjects 18 years of age or greater. A 25(OH) vitamin D level between 10 and 30 ng/ml were considered for enrollment.
9 Study design cont. A total of 249 subjects completed the study. Results were assessed by improvement in repeat serum 25(OH) vitamin D levels obtained following 12 weeks of replacement therapy. Subject received vitamin D supplements.
10 Study design cont. Duration of treatment was 12 weeks. Formal consent was obtained and signed by the patients. Demographics, vitamin D levels, medical history and medication list was obtained.
11 Study design cont. Out of 249 patients, 210 patients were included in the study. 70 patients were taking PPI at the time and during the study. 140 patients were not on any medications like (PPI, steroids, or anticonvulsants)
12 Inclusion Criteria Men and women were included. Age 18. Vitamin D levels 10 and <30ng/ml.
13 Exclusion Criteria Vitamin D levels below 10 ng/dl. Malabsorption syndrome. Intestinal bypass. Chronic liver or kidney disease. Sever SLE. Sever Scleroderma. History of cancer within the last 5 years.
14 End Points % increase in 25 OH vitamin D levels from baseline. Results were compared between the two groups.
15 Statistics Unpaired t tests to compare two groups of subjects. P value is less than 0.05 considered statistically significant.
16 Demographics PPI no PPI Subjects Gender 16M/54F 25M/115F Age 57 ±12 51 ± 13 BMI 32±6 31±6
17 Mean vitamin D dose P value 0.27
18 BMI P value 0.31
19 Change in Vitamin D levels
20 % increase in vitamin D levels P value 0.006
21 Results The mean improvement in 25(OH) vitamin D levels for the PPI group was 40% with a mean raw difference of 9.5 (95% CI ). No PPI group demonstrated a mean improvement of 60 % with a mean difference of 14.2 (95% CI ). The improvement in 25(OH) vitamin D levels in the no PPI "cohort was 49% greater than those taking a PPI. (p=0.006).
22 Proposed mechanism PPI s Chronic gastric acid suppression Bacterial flora growth Nutritional malabsorption Williams C. Best Pract Res Clin Gastroenterol 2001;15: Theisen, Jörg, et al. " Journal of Gastrointestinal Surgery (2000): Rana S, Bhardwaj S. Scand J Gastroenterol. 2008;43:
23 Limitations Study was not blinded. Single center study.
24 Recommendations Revaluate the need for PPI. Regular vitamin D levels measurements. Further larger studies to be conducted.
25 Thank YOU!
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