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Rani Hanna M.D., M.S. PGY-3Joseph Grisanti, MD
A study to Evaluate PPI’s effect on vitamin D levels
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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.
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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;357:266-281
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Proton pump inhibitors
• Progressively increased use over the past 25 years.• 113.4 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.
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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): 225-233.• Sarkar, Monika, et al. Annals of Internal Medicine149.6 (2008): 391-398.• Pezalla,et al. (2008).journal of American College of Cardiology, 52, 1038-1039.
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Side effect cont.
• Vitamins and minerals deficiencies.• Vitamin B12• Vitamin C• Calcium • Iron • Magnesium
• Howden, Colin W. Journal of clinical gastroenterology 30.1 (2000): 29-33.• 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): 887-889.•Cundy, Tim, Mackay. " Current opinion in gastroenterology 27.2 (2011): 180-185.
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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.
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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.
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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.
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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.
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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)
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Inclusion Criteria
• Men and women were included.• Age ≥18. • Vitamin D levels ≥10 and <30ng/ml.
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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.
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End Points
• % increase in 25‐OH vitamin D levels from baseline.
• Results were compared between the two groups.
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Statistics
• Unpaired t‐tests to compare two groups of subjects.
• P‐value is less than 0.05 considered statistically significant.
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Demographics
PPI no PPI
Subjects 70 140
Gender 16M/54F 25M/115F
Age 57 ±12 51 ± 13
BMI 32±6 31±6
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Mean vitamin D dose
P value 0.27
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BMI
P value 0.31
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Change in Vitamin D levels
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% increase in vitamin D levels
P value 0.006
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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 7.2‐11.9).
• “No PPI” group demonstrated a mean improvement of 60 % with a mean difference of 14.2 (95% CI 12.3‐16.2).
• The improvement in 25(OH) vitamin D levels in the ‘”no PPI "cohort was 49% greater than those taking a PPI. (p=0.006).
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Proposed mechanism
PPI’s
Chronic gastric acid suppression
Bacterial flora growth
Nutritional malabsorption
• Williams C. Best Pract Res Clin Gastroenterol 2001;15:511–521•Theisen, Jörg, et al. " Journal of Gastrointestinal Surgery (2000): 50-54.• Rana S, Bhardwaj S. Scand J Gastroenterol. 2008;43:1030–1037.
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Limitations
• Study was not blinded.• Single center study.
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Recommendations
• Revaluate the need for PPI.• Regular vitamin D levels measurements.• Further larger studies to be conducted.
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Thank YOU!