DNP Clinical Project Texas Christian University

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1 Use of a Guideline to Diagnose and Treat Vitamin D Deficiency to Optimize 25(OH)D Level DNP Clinical Project Texas Christian University Tricia L. Butner DNP, ARNP Quest for Quality Conference September 10, 2010

2 Use of a Guideline to Diagnose and Treat Vitamin D Deficiency to Optimize 25(OH)D Level Setting: A family practice clinic in S.E. Oklahoma Target population: Non-pregnant female and male patients over 18. Timeframe: September February 2010

3 Seminole Medical Clinic

4 Conceptual Framework Stevens, K. R. (2004). ACE Star Model of EBP: Knowledge Transformation. Academic Center for Evidence-based Practice. The University of Texas Health Science Center at San Antonio.

5 Discovery New knowledge is generated as a result of scientific inquiry and research (Stevens, 2004). Vitamin D deficiency was identified as a problem affecting a majority of patients in my family practice. No clear guideline was found to assist practitioners in identifying, treating, or monitoring patients with vitamin D deficiency.

6 Literature Review and Synthesis New evidenced-based knowledge about vitamin D deficiency was identified that had not been translated into formal guidelines for practice.

7 Vitamin D Deficiency Vitamin D deficiency is epidemic, present in 50 to 75 % of the general population (Ginde, 2009). Research has shown vitamin D is actually not a vitamin, but a potent repair and maintenance hormone that targets over 2000 genes. Most tissues and cells in the body (over 36 target organs) have a vitamin D receptor (VDR), capable of converting 25(OH)D to the active form (Holick, 2007; Cannell et al., 2008).

8 Lifestyle Factors in Vitamin D Deficiency Vitamin D is produced in the skin, from exposure to the sun, or from ultraviolet B light. For 30 years, fear of skin cancer, use of sunscreen and various lifestyle factors have prevented many people from getting vitamin D from the sun.

9 Negative Impact of Vitamin D Deficiency Increasing number of diseases associated with vitamin D deficiency: cancer, cardiovascular disease, hypertension, diabetes, asthma, multiple sclerosis, autoimmune diseases, inflammatory bowel disease, chronic pain, muscle weakness, fractures, and more (Giovannucci, 2009).

10 Vitamin D Deficiency Associated with Seven Priority Chronic Diseases. 1. Heart Disease (Lee et al., 2008) 2. Stroke (Lee et al., 2008). 3. Cancer (Lappe et al., 2007) 4. Diabetes (Pittas et al., 2007) 5. Asthma (Brehm et al., 2009) 6. Arthritis (Kröger et al., 1993) 7. Periodontal Disease (Dietrich et al., 2004)

11 Vitamin D and Cardiovascular Risk A 10 year study of 18,000 male health professionals age initially free of heart disease, found men who were deficient in vitamin D had a 2.42 times greater risk of heart problems compared to men with higher vitamin D levels (Giovannucci et al., 2008). A study of 3316 patients with suspected coronary artery disease found a startling 86% increase in fatal strokes with only a small decrease in vitamin D status (Pilz et al., 2008).

12 Vitamin D and Cancer Vitamin D controls the genes responsible for the regulation of cellular proliferation, differentiation, apoptosis, and angiogenesis (Nagpal & Rathnachalam, 2005). A 4 year, double blind, randomized trial found improving vitamin D status substantially reduced the risk of all cancer, including breast cancer, by percent in post menopausal women (Lappe et al., 2007).

13 Limited Amount of Vitamin D in Food Current guideline (AI) for vitamin D is IU/day, and food fortification aims for 400 IU/day (ODS, 2009). Consumption of 400 IU of vitamin D in food does not prevent vitamin D deficiency (Cannell & Hollis, 2008).

14 Safety of Vitamin D The safe upper limit (NOAEL) for vitamin D is currently 2000 IU/day (Vieth et al., 2001). Recent research: safe upper limit should be 10,000 IU per day of vitamin D (Hathcock et al., 2007).

15 Risk Factors for Vitamin D Deficiency 1. Age over Race (Dark Skin) 3. BMI (30 or higher) 4. Limited dietary intake 5. Limited or no sun exposure 6. Limited or no supplementation (<2000 IU/day) 7. Medications/GI surgery or disease

16 Vitamin D 2000 IU/Day 2008: 16 prominent scientists called for universal oral intake of 2000 IU of vitamin D3 in an effort to prevent the diseases in which vitamin D deficiency plays a role (Garland et al., 2008). AMA and the American Public Health Association called for revision of guidelines for vitamin D intake (Stein, 2008; Baggerly, 2009).

17 Minimal and Optimal 25(OH)D Range Minimal level: 32ng/mL Optimal level: ng/ml (Binkley et al., 2007; Bischoff- Ferrari, 2006; (Giovannuci, 2009; Holick & Chen, 2008; Hollis, 2005 ). Higher level (55-70 ng/ml): for serious illnesses associated with vitamin D deficiency (Cannell & Hollis, 2008). Best lab test: Serum 25(OH)D (Holick, 2007; Cannel & Hollis, 2008).

18 Few Contraindications to Vitamin D Supplementation Allergy or sensitivity Hypercalcemia Sarcoidosis Non-Hodgkin s Lymphoma Oat Cell Lung Cancer

19 Failure to Diagnose and Treat Vitamin D Deficiency The new knowledge about the importance of optimal vitamin D levels in health is not being translated into practice, and guidelines for treatment with vitamin D supplements are not commonly known by practitioners.

20 Implementation After consent, the guideline questionnaire was administered to identify risk factors for vitamin D deficiency. Participants had baseline 25(OH)D lab drawn. A vitamin D3 dosage was recommended according to treatment guideline. Post-treatment 25(OH)D lab was drawn after 2-3 months of taking D3 supplement.

21 Receptionist & Nursing Staff

22

23 Vitamin D3 Dosage Guideline 25()H)D Level Dosage 4-20 Add 50,000 IU vitamin D3 per week, or IU/day for 2-3 months.* Add 50,000 IU vitamin D3 the first day, then IU/day for 2-3 months.* Add IU/day for 3 months Add none to 2000 IU of vitamin D3/day for 3-6 months. Check 25(OH)D level in 3-6 months Continue current vitamin D3 dosage. Check 25(OH)D level in 3-6 months * Check 25(OH)D lab in 2-3 months.

24 Drawing 25(OH)D Lab

25 Outcomes Primary Outcome: (1) Accurate identification of patients at risk for vitamin D deficiency (2) Effective treatment to raise 25(OH)D to optimal range (40-70 ng/ml). Secondary Outcome: Compliance (1) Participant will take vitamin D3 supplement as directed (2) Participant will have baseline and post-treatment 25(OH)Dlab drawn

26 First Process Evaluated: Effectiveness of Guideline Risk factors: correlated with base 25(OH)D levels to determine if participants at risk for vitamin D deficiency were accurately identified. Baseline and post-treatment 25(OH)D levels: compared to determine if the guideline was effective in raising 25(OH)D to an optimal range.

27 Second Process Evaluated: Compliance The dosage of vitamin D3 taken was compared with the dosage recommended by the practitioner. Baseline and post-treatment 25(OH)D levels were compared according to compliance participants.

28 Demographic Results 60 participants: yrs Mean age: 55 (SD = 17) 43 (72%) females 51 Light Skin Racial Group 17 (28%) males 9 Dark Skin Racial Group Normal D Group (n=5) 25(OH)D 32 ng/ml or higher Low D Group (n=55) 25(OH)D < 32 ng/ml Medical history correlated with base 25(OH)D level. (Race, BMI, Risk Factors, and Disease Total)

29 RACE Dark Skin Racial Group (n = 9): Mean 25(OH)D 16.5 ng/ml (SD=3.8) Light Skin Racial Group (n = 51): Mean 25(OH)D 21.9 ng/ml (SD=7.6) Dark Skin Racial Group: 25(OH)D significantly lower than the Light Skin Racial Group (p = 0.044). (Two Sample t-test for Means)

30 25(OH)D Race and 25(OH)D Level Dark Skin Racial Group Light Skin Racial Group

31 BMI BMI range: 20 to 53 Mean 33 (SD=8) Normal D Group (n=5): Mean BMI 26 (SD=5.7) Low D Group (n=55): Mean BMI 33 (SD=8.2) BMI was significantly higher in the Low D group than in the Normal D Group (p = 0.000). Two Sample t-test for Means

32 BMI BMI and 25(OH)D Normal D Group Low D Group

33 7 Risk Factors for Deficiency Normal D Group mean risk factors: 3.2 (SD=1.1) Low D Group mean risk factors: 4.8 (SD=0.45) Low D Group: significantly more risk factors than the Normal D Group (p = 0.002). Two Sample t-test for Means [Age, race, BMI, limited dietary intake, limited or no sun exposure, limited or no supplementation (<2000 IU/day), medications/gi disease]

34 Number of Risk Factors Risk Factors Normal D Group Low D Group > 32 ng/ml 25(OH)D Level < 32 ng/ml

35 Mean Disease Total: Disease Total Normal D Group (n=3*): 1 disease (SD=1) Low D Group (n=55): 4.2 diseases (SD=2.1) *(2 participants excluded.) Disease Total in the Normal D group was significantly less than the Low D Group (p = ). Two Sample t-test for Means

36 Number of Diseases Disease Total Normal D Group 25(OH)D > 32 ng/ml Low D Group 25(OH)D < 32 ng/ml

37 Project Results Baseline 25(OH)D range: 6 to 47 ng/ml Mean 21.1 (SD 7.4), median 21.0, mode 21.0 Before Nov 1 st : (n=39) Mean 25(OH)D 23.5 ng/ml (SD=7.5) After November 1 st : (n=21) Mean 25(OH)D 16.7 ng/ml (SD=4.8)

38 Number of Participants Base 25(OH)D Range Histogram Up To To To To To To To To To 50 More 25(OH)D Level

39 25(OH)D Level Sept. to Dec. Decline in 25(OH)D Time of Year: September to December 2009

40 25(OH)D Level 25(OH)D Before and After Midpoint Before Nov 1st Midpoint After Nov 1st Midpoint Time Period: September to December 2009

41 Outcome: Questionnaire was Effective 55 of 60 participants (92 %), identified by the questionnaire, as possibly at risk for vitamin D deficiency, had 25(OH) levels below 32 ng/ml. Only 5 participants (8%) had 25(OH)D levels above 32 ng/ml (i.e., 32, 33*, 33, 36*, 47). *(Participant already on 1800IU/day of vitamin D3.)

42 Post-treatment 25(OH)D 56 of 60 participants (93%) completed the project: 1 died of non-project related causes 3 did not return for lab Post-treatment 25(OH)D range: ng/ml. Mean post-treatment 25(OH)D: 42.6 (SD=17.1)

43 25(OH)D Level Base and Post 25(OH)D Base 25(OH)D (All Participants) Post 25(OH)D

44 Base and Post 25)OH(D Levels Base and Post-treatment 25(OH)D Participants

45 Outcome: Guideline was Effective in Compliant Participants 100% of dose compliant participants increased 25(OH)D above 40 ng/ml. 94% of compliant participants increased 25(OH)D to optimal range (40-70 ng/ml).* *One compliant participant had a 25(OH)D of 82, above optimal range, but below upper limit of normal (100 ng/ml).

46 Decreased Compliance Reduced Effectiveness of the Guideline 39 of 56 participants (70%) had post-treatment 25(OH)D levels above the lower limit of normal (32 ng/ml). 28 of 56 participants (50 %) achieved optimal vitamin D levels (40-70 ng/ml).

47 Post-treatment 25(OH)D Level 25 (OH)D by Compliance Group High Compliance Mod. Compliance Low Compliance High Compliance Low High Compliance D Group Normal D Group Mod Compliance Low Low Compliance Low D Group D Group Low Compliance Normal D Group

48 Conclusion The recommended daily intake ( IU) for vitamin D is inadequate. Much higher doses( IU/day) were needed to raise 25(OH)D levels from a mean of 21 to an optimal range of ng/ml.

49 In Summary Raising the minimum acceptable level to ng/ml would prevent approximately 58,000 new cases of breast cancer, and 49,000 new cases of colorectal cancer yearly, and 75% of deaths from these diseases in the U. S. and Canada. (Garland et al., 2009)

50 A Perfect Storm Living most of life indoors and using sunscreen outdoors has resulted in an epidemic of vitamin D deficiency. Vitamin D3 supplementation could improve the quality of life for millions of people, and save thousands of lives.

51 Ask your doctor if taking a pill to solve all your problems is right for you

52 The evidence is convincing, the risks are minimal. Failure to translate this knowledge into practice could have major ethical and legal ramifications for practitioners and devastating health consequences for patients.

53 Conclusion Vitamin D for Health and Life

54 Are YOU taking YOUR Vitamin D?

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