CONCORD INTERNAL MEDICINE VITAMIN D/CALCIUM/MAGNESIUM PROTOCOL Douglas G. Kelling, Jr., ND C. Gismondi-Eagan, MD, FACP George C. Monroe, III, MD Revised April 8, 2012 The information contained in this protocol should never be used as a substitute for clinical judgment. The clinician and the patient need to develop an individual treatment plan that is tailored to the specific needs and circumstances of the patient.
Vitamin D/Calcium/Magnesium Protocol Table of Contents Page(s) 25 Hydroxyvitamin D Levels 1-7 1,25-Dihydroxyvitamin D Levels 8-9 Urinary Calcium/Creatinine Ratio 10 Magnesium Tolerance Test 11 Treatment with Magnesium Oxide 12 Malabsorption Workup 13
Page 1 VITAMIN D/CALCIUM/MAGNESIUM PROTOCOL IN PATIENTS WITH AN ABNORMAL DXA SCAN, NON-TRAUMATIC FRACTURE OR LOW SERUM CALCIUM MEASURE 25 HYDROXYVITAMIN D LEVEL AND ipth LEVEL (Draw 8am to 10am) 25-Hydroxyvitamin D < 20 25-Hydroxyvitamin D > 20 and < 30 25-Hydroxyvitamin D > 30 ipth > 65 if GFR > 60 ipth > 70 if GFR 30-59 ipth > 110 if GFR 15-29 ipth > 300 if GFR < 15 or dialysis ipth < 65 if GFR > 60 ipth < 70 if GFR 30-59 ipth < 110 if GFR 15-29 ipth < 300 if GFR < 15 or dialysis ipth > 65 if GFR > 60 ipth > 70 if GFR 30-59 ipth > 110 if GFR 15-29 ipth > 300 if GFR < 15 or dialysis ipth < 65 if GFR > 60 ipth < 70 if GFR 30-59 ipth < 110 if GFR 15-29 ipth < 300 if GFR < 15 or dialysis Page 6 Page 2 Page 3 Page 4 Page 5
Page 2 25 Hydroxyvitamin D Level < 20 ipth > 65 if GFR > 60 ipth > 70 if GFR 30-59 ipth > 110 if GFR 15-29 ipth > 300 if GFR < 15 or dialysis Elevated Serum Calcium Endocrinologist to evaluate for Primary Hyperparathyroidism Normal Serum Calcium or Normal serum corrected calcium (cca) Low and low cca *Elemental Calcium 500 mg/bid daily Vitamin D 50,000 IU weekly x 8 weeks then continue monthly In 12 weeks, Remeasure: Serum cca if clinically indicated 25-Hydroxyvitamin D ipth (Draw 8am to 10am) Page 7 *Consider using calcium citrate if the patient has a history of kidney stones and patient s creatinine clearance is >60, otherwise use Calcium carbonate. If patient has a history of kidney stones measure urinary calcium/creatinine ratio before and 12 wks after starting calcium supplementation.
Page 3 25 Hydroxyvitamin D Level < 20 ipth < 65 if GFR > 60 ipth < 70 if GFR 30-59 ipth < 110 if GFR 15-29 ipth < 300 if GFR < 15 or dialysis Elevated First measurements of serum Calcium, 25 Hydroxyvitamin D and ipth levels? Normal or normal serum corrected calcium (cca) Low And cca *Elemental Calcium 500 mg/bid daily No Remeasure Serum Calcium, 25 Hydroxyvitamin D and intact PTH levels Page 1 Reevaluate Patient Vitamin D 50,000 IU weekly x 8 weeks In 12 weeks, Remeasure: Serum cca if clinically indicated 25-Hydroxyvitamin D ipth (Draw 8am to 10am) Magnesium Tolerance Test Page 11 Page 7 *Consider using calcium citrate if the patient has a history of kidney stones and patient s creatinine clearance is >60, otherwise use calcium carbonate. If patient has a history of kidney stones measure urinary calcium/creatinine ratio before and 12 wks after starting calcium supplementation.
Page 4 25 Hydroxyvitamin D Level > 20 AND < 30 ipth > 65 if GFR > 60 ipth > 70 if GFR 30-59 ipth > 110 if GFR 15-29 ipth > 300 if GFR < 15 or dialysis Elevated serum Calcium Endocrinologist to evaluate for Primary Hyperparathyroidism Normal Or normal serum corrected calcium (cca) *Elemental Calcium 500 mg/bid daily Vitamin D 50,000 IU weekly x 4 weeks Low and low cca *Elemental Calcium 500 mg/tid daily Vitamin D 50,000 IU weekly x 4 weeks Normal Repeat High In 12 weeks, Remeasure: Serum cca if clinically indicated 25-Hydroxyvitamin D ipth (Draw 8am to 10am) 8am Spot urine for NTx Vitamin D 50,000 IU Weekly x 2 weeks Endocrinologist to evaluate for Primary Hyperparathyroidism Stop Calcium, Multivitamin and Vitamin D Page 7 *Consider using calcium citrate if the patient has a history of kidney stones and patient s creatinine clearance is >60, otherwise use Calcium carbonate. If patient has a history of kidney stones measure urinary calcium/creatinine ratio before and 12 wks after starting calcium supplementation.
Page 5 25-Hydroxyvitamin D Level > 20 AND < 30 ipth < 65 if GFR > 60 ipth < 70 if GFR 30-59 ipth < 110 if GFR 15-29 ipth < 300 if GFR < 15 or dialysis Elevated serum Calcium Normal or normal serum corrected calcium (cca) Low and low cca First measurements of serum Calcium, 25 Hydroxyvitamin D and ipth levels? *Elemental Calcium 500 mg/bid daily *Elemental Calcium 500 mg/tid daily No Reevaluate patient Vitamin D 50,000 IU weekly x 4 weeks Magnesium Tolerance Test Page 11 Remeasure Serum Calcium, 25 Hydroxyvitamin D and ipth levels Page 1 In 12 weeks, Remeasure: Serum cca of clinically indicated 25-Hydroxyvitamin D ipth (Draw 8am to 10am) 8 am Spot urine for NTx Page 7 *Consider using calcium citrate if the patient has a history of kidney stones and patient s creatinine clearance is >60, otherwise use calcium carbonate. If patient has a history of kidney stones measure urinary calcium/creatinine ratio before and 12 wks after starting calcium supplementation.
Page 6 25 Hydroxyvitamin D Level > 30 Yes Is calculated GFR is > 60? No See Chronic Kidney Disease (CKD) protocol Low, low cca, and High ipth Level Elevated and low ipth Level Normal or elevated Serum Calcium and High ipth Level Normal serum calcium and Normal ipth Measure 1,25 Dihydroxyvitamin D Level 1,25-Dihydroxy- Vitamin D Level < 20 1,25-Dihydroxy- Vitamin D Level > 20 Consider granulomalous disease, lymphoma, or TB Endocrinologist to evaluate for Primary Hyperparathyroidism *Elemental Calcium 500 mg BID with food PLUS Vitamin D 50,000 units twice a month (suggest 1 st & 15 th each month) See Page 8 See Page 9 Low or normal serum calcium and Low ipth Elevated and Low ipth level 25 hydroxyvitamin D level yearly First measurements of serum calcium, 25 Hydroxyvitamin D and ipth levels? Measure PTH-like peptide See Page 1 *Consider using calcium citrate if the patient has a history of kidney stones, and patient s creatinine clearance is >60, otherwise use calcium carbonate. No Remeasure serum Calcium, 25 Hydroxyvitamin D and ipth levels Reevaluate patient Elevated PTHlike peptide Evaluate for metastatic cancer Normal PTH-like peptide Measure urinary Calcium/Creatinine ratio If patient has a history of kidney stones measure urinary calcium/creatinine ratio before and 12 wks after starting calcium supplementation. See Page 1 Re-evaluate patient
Page 7 25 Hydroxyvitamin D Level Remeasured after treatment with high dose Vitamin D 25-Hydroxyvitamin D < 20 25-Hydroxyvitamin D >20 < 30 25-Hydroxyvitamin D > 30 Malabsorption workup Page 13 Vitamin D 50,000 IU weekly x 4 weeks page 6 Urine dipstick for protein Remeasure 25-Hydroxyvitamin D Level Negative for protein Positive for protein 25-Hydroxyvitamin D <30 25-Hydroxyvitamin D > 30 No further work up 24 hour urine for protein and creatinine >4 grams of protein in 24 hr urine Malabsorption Workup Page 13 Nephrologist for evaluation of nephrotic syndrome Measure Vitamin D- binding protein
Page 8 1,25-Dihydroxyvitamin D Level Low 1,25-Dihydroxyvitamin D (Rocaltrol) 0.25 mcg po BID x 8 weeks Re-measure 1,25-Dihydroxyvitamin D Level 1,25-Dihydroxyvitamin D Level low 1,25-Dihydroxyvitamin D Level normal 1,25-Dihydroxyvitamin D Level high 1,25-Dihydroxyvitamin D (Rocaltrol) 0.25 mcg po BID x 4 weeks Re-measure 1,25-Dihydroxy- Vitamin D Level ipth level within normal limits Measure PTH Level (Draw 8am to 10am) Elevated ipth Level Stop Rocaltrol Physician to re-evaluate patient 1,25-Dihydroxyvitamin D Level low 1,25-Dihydroxyvitamin D Level normal Measure serum Calcium and cca if clinically indicated Malabsorption work up Page 13 and cca within normal limits Low Serum Calcium and low cca if measured Low serum calcium and low cca if measured Normal or elevated serum calcium or normal or elevated cca No further work up Page 9 Endocrinologist
Page 9 Measure urinary Calcium/Creatinine Ratio < 0.2 mg for women < 0.25 mg for men >0.2 mg to 0.25 mg for women >.25 mg to 0.3 mg for men > 0.25 mg for women > 0.3 mg for men Make sure patient taking total of 1500 mg of elemental Calcium a day Magnesium Tolerance Test (Valid only if patient has normal renal functioncalculated GFR >60 Page 11 Magnesium Retention >25% Magnesium Retention < 25% In 3 months remeasure urinary Calcium/Creatinine Ratio Magnesium Deficiency Treat with Magnesium Oxide Page 11 Treat for Idiopathic Hypercalciuria Magnesium Tolerance Test - Page 10 Magnesium Retention >25% Magnesium Retention <25% Magnesium Deficiency Treat with Magnesium oxide Page 11 Re-evaluate Patient
Page 10 MAGNESIUM TOLERANCE TEST Valid only if patient has normal renal function (calculated GFR > 60) Collect 24-hour urine for magnesium and creatinine. (Computer code MAGUPR) Once the initial 24 hour urine collection is completed, infuse 0.2 meq (2.4mg) elemental magnesium per Kg lean body weight in 50ml 5% dextrose over a 4 hour period. At the start of the magnesium infusion, begin another 24 hour urine collection for magnesium and creatinine (Computer Code MAGUPO) Date Time Physician Signature Patient Sticker NORTHEAST MEDICAL CENTER STANDING ORDERS DR. KELLING MAGNESIUM TOLERANCE TEST RESULTS OF MAGNESIUM TOLERANCE TEST Magnesium Retention <25% Magnesium Retention >25% No evidence magnesium deficiency Magnesium Deficiency Treat with Magnesium oxide See Page 11 Re-evaluate Patient
Page 11 Treatment with Magnesium Oxide Creatinine Clearance > 30 Magnesium Oxide 400mg BID Patient intolerant of dose No Yes Measure serum magnesium level 1 and 3 weeks after beginning Magnesium Oxide Decrease dose to Magnesium Oxide 400mg Low Serum Magnesium Normal Serum Magnesium High Serum Magnesium Patient intolerant of dose No Yes Increase Magnesium Oxide by 400mg a day Continue same dose magnesium oxide Stop Magnesium Oxide and re-evaluate patient Re-evaluate patient Measure Serum Magnesium level 1 and 3 weeks after increasing the dose of Magnesium Oxide Repeat serum magnesium level as clinically indicated Patient intolerant of dose No Yes Re-evaluate patient Low Serum Magnesium Normal Serum Magnesium High Serum Magnesium Re-evaluate patient Continue same dose magnesium oxide Stop Magnesium Oxide and re-evaluate patient Repeat serum magnesium level as clinically indicated
Page 12 Malabsorption Workup Measure: D-xylose test Serum IgA level IgA antitissue transglutaminase antibody Osteocalcin (if not already measured) Antibodies positive and D-xylose test abnormal Antibodies negative and D-xylose test abnormal Antibodies negative and D-xylose test normal GI for further evaluation for sprue GI for further evaluation of causes of mucosal malabsorption other than sprue GI to evaluate for pancreatis insufficiency