Vitamin D compounds for people with chronic kidney disease not requiring dialysis

Suetonia C Palmer; David O McGregor; Jonathan C Craig; Grahame Elder; Petra Macaskill; Giovanni FM Strippoli

doi:10.1002/14651858.CD008175

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Figure 1

Mineral metabolism in chronic kidney disease

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Analysis 1.1

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 1 All‐cause mortality.

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Analysis 1.2

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 2 Commencement of dialysis.

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Analysis 1.3

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 3 Fracture.

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Analysis 1.4

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 4 Parathyroidectomy.

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Analysis 1.5

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 5 Improvement in bone histomorphometry.

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Analysis 1.6

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 6 End of treatment osteoid volume (mm³/cm³).

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Analysis 1.7

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 7 End of treatment osteoid thickness (µm).

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Analysis 1.8

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 8 Development of osteitis fibrosa.

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Analysis 1.9

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 9 Development of osteomalacia.

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Analysis 1.10

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 10 End of treatment parathyroid hormone (pg/mL).

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Analysis 1.11

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 11 Reduction of serum PTH > 30% from baseline value.

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Analysis 1.12

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 12 One or more episodes of hypercalcaemia.

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Analysis 1.13

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 13 One or more episodes of hyperphosphataemia.

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Analysis 1.14

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 14 One or more episodes of elevated calcium x phosphorus product.

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Analysis 1.15

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 15 End of treatment serum phosphorus (mg/dL).

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Analysis 1.16

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 16 End of treatment serum calcium (mg/dL).

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Analysis 1.17

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 17 End of treatment alkaline phosphatase (U/L).

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Analysis 1.18

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 18 End of treatment CrCl (mL/min).

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Analysis 1.19

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 19 End of treatment absolute BMD femoral neck (g/cm²).

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Analysis 1.20

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 20 End of treatment absolute BMD lumbar spine (g/cm²).

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Analysis 1.21

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 21 Worsening vascular calcification.

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Analysis 1.22

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 22 Development of vascular calcification.

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Analysis 1.23

Comparison 1 Vitamin D versus placebo/no treatment, Outcome 23 Withdrawal of treatment due to hypercalcaemia.

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Analysis 2.1

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 1 All‐cause mortality.

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Analysis 2.2

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 2 Commencement of dialysis.

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Analysis 2.3

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 3 Fracture.

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Analysis 2.4

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 4 Parathyroidectomy.

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Analysis 2.5

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 5 Improvement in bone histomorphometry.

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Analysis 2.6

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 6 Development of osteitis fibrosa.

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Analysis 2.7

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 7 Development of osteomalacia.

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Analysis 2.8

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 8 End of treatment osteoid volume (mm³/cm³).

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Analysis 2.9

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 9 End of treatment osteoid thickness (µm).

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Analysis 2.10

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 10 End of treatment parathyroid hormone (pg/mL).

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Analysis 2.11

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 11 One or more episodes of hypercalcaemia.

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Analysis 2.12

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 12 One or more episodes of hyperphosphataemia.

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Analysis 2.13

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 13 One or more episodes of elevated calcium x phosphorus product.

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Analysis 2.14

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 14 Withdrawal of treatment due to hypercalcaemia.

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Analysis 2.15

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 15 End of treatment serum phosphorus (mg/dL).

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Analysis 2.16

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 16 End of treatment serum calcium (mg/dL).

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Analysis 2.17

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 17 End of treatment alkaline phosphatase (U/L).

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Analysis 2.18

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 18 End of treatment CrCl (mL/min).

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Analysis 2.19

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 19 End of treatment absolute BMD femoral neck (g/cm²).

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Analysis 2.20

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 20 End of treatment absolute BMD lumbar spine (g/cm²).

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Analysis 2.21

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 21 Worsening vascular calcification.

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Analysis 2.22

Comparison 2 Established vitamin D versus placebo/no treatment, Outcome 22 Development of vascular calcification.

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Analysis 3.1

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 1 All‐cause mortality.

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Analysis 3.2

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 2 Commencement of dialysis.

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Analysis 3.3

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 3 Reduction of serum PTH > 30% from baseline value.

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Analysis 3.4

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 4 End of treatment parathyroid hormone (pg/mL).

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Analysis 3.5

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 5 End of treatment serum calcium (mg/dL).

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Analysis 3.6

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 6 End of treatment serum phosphorus (mg/dL).

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Analysis 3.7

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 7 One or more episodes of hypercalcaemia.

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Analysis 3.8

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 8 One or more episodes of hyperphosphataemia.

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Analysis 3.9

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 9 One or more episodes of elevated calcium x phosphorus product.

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Analysis 3.10

Comparison 3 Newer vitamin D versus placebo/no treatment, Outcome 10 End of treatment CrCl (mL/min).

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Analysis 4.1

Comparison 4 Intermittent vitamin D versus daily vitamin D, Outcome 1 One or more episodes of hypercalcaemia.

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Table 1. Stages of chronic kidney disease (KDOQI)

CKD stage	GFR range
1	≥ 90 mL/min/1.73 m² with kidney damage for ≥3 months as defined by structural or functional abnormalities of the kidney
2	60‐89 mL/min/1.73 m²
3	30‐59 mL/min
4	15‐29 mL/min
5	< 15 mL/min or dialysis

Table 1. Stages of chronic kidney disease (KDOQI)

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Table 2. Current guidelines for the use of vitamin D compounds in chronic kidney disease

Guideline	Country	Year	Recommendation
Kidney Disease Outcomes Quality Initiative	USA	2003	Patients treated with HD or PD with serum levels of intact PTH levels > 300 pg/mL) (33.0 pmol/L) should receive an active vitamin D sterol (such as calcitriol, alfacalcidol, paricalcitol, or doxercalciferol) to reduce the serum levels of PTH to a target range of 150‐300 pg/mL (16.5‐33.0 pmol/L). (EVIDENCE) The intermittent, IV administration of calcitriol is more effective than daily oral calcitriol in lowering serum PTH levels. (EVIDENCE) In patients with corrected serum calcium and/or phosphorus levels above the target range, a study of alternative vitamin D analogs, such as paricalcitol or doxercalciferol may be warranted. (OPINION) When either HD or PD patients are treated with active vitamin D sterols, management should integrate the changes in serum calcium, serum phosphorus, and plasma PTH.
Caring for Australasians with Renal Impairment	Australasia	2006	Oral calcitriol (intermittent or pulsed) is effective at lowering parathyroid hormone levels in patients on PD (Level II evidence). Vitamin D and its analogs, either given orally daily, orally intermittently, or intravenously are effective at lowering PTH levels in patients on HD (Level I/II evidence). Oral calcitriol is effective for the prevention or treatment of hyperparathyroidism in most patients on HD or PD. IV calcitriol may be more effective at lowering PTH levels and be less likely to cause hypercalcaemia but the lack of well‐designed studies of sufficient size prevents a more definitive statement. Vitamin D analogs are effective at lowering PTH but clinical studies proving their effectiveness with fewer side‐effects prevents are either lacking or not definitive. On the basis of current evidence there is little reason to recommend their use over oral or IV calcitriol.
British Renal Society	UK	2007	The relative importance of hyperparathyroidism as a risk factor for premature vascular disease is difficult to determine from observational studies and no informative RCTs exist. There is no doubt that a serum PTH concentration over 4 times the normal limit is associated with increased risk of significant bone disease and should therefore be avoided by medical (or if necessary surgical) management of hyperparathyroidism. In the absence of firm evidence, individual clinicians should decide on the degree to which hyperparathyroidism should be corrects and how this should be achieved.
European Best Practice Guidelines (EBPG)	Europe	2002	No guideline
Europe ‐‐ expert panel (including members from Fresenius Medical Care) (not EBPG)	Europe	2001	PTH above 9‐18 pmol/L (78‐156 pg/mL) may well be treated with small daily doses of active vitamin D. IV pulse administration does not have any advantage over oral route. No evidence from direct comparative studies to show any superiority of maxacalcitol, doxercalciferol, or paricalcitol over calcitriol or alfacalcidol.
Canadian Society of Nephrology	Canada	2006	Avoid intact PTH (iPTH) levels < 100 pg/mL (10.6 pmol/L (Grade C); iPTH levels > 500 pg/mL (53 pmol/L) should be treated if accompanied by symptoms or clinical signs of hyperparathyroidism. Vitamin D analogs should be used in conjunction with a specialist. There is insufficient evidence to recommend use of novel vitamin D analogs (grade D, opinion)
HD ‐ haemodialysis; PD ‐ peritoneal dialysis

Table 2. Current guidelines for the use of vitamin D compounds in chronic kidney disease

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Comparison 1. Vitamin D versus placebo/no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	4	477	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.38, 5.15]

2 Commencement of dialysis Show forest plot	4	301	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.36, 1.62]

3 Fracture Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4 Parathyroidectomy Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5 Improvement in bone histomorphometry Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

6 End of treatment osteoid volume (mm³/cm³) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

7 End of treatment osteoid thickness (µm) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

8 Development of osteitis fibrosa Show forest plot	2	43	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.23, 1.29]

9 Development of osteomalacia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

10 End of treatment parathyroid hormone (pg/mL) Show forest plot	4	153	Mean Difference (IV, Random, 95% CI)	‐49.34 [‐85.70, ‐12.97]

11 Reduction of serum PTH > 30% from baseline value Show forest plot	2	264	Risk Ratio (M‐H, Random, 95% CI)	7.87 [4.87, 12.73]

12 One or more episodes of hypercalcaemia Show forest plot	7	612	Risk Ratio (M‐H, Random, 95% CI)	3.04 [1.17, 7.90]

13 One or more episodes of hyperphosphataemia Show forest plot	2	245	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.47, 5.30]

14 One or more episodes of elevated calcium x phosphorus product Show forest plot	3	300	Risk Ratio (M‐H, Random, 95% CI)	1.63 [0.57, 4.66]

15 End of treatment serum phosphorus (mg/dL) Show forest plot	3	140	Mean Difference (IV, Random, 95% CI)	0.37 [0.09, 0.66]

16 End of treatment serum calcium (mg/dL) Show forest plot	5	184	Mean Difference (IV, Random, 95% CI)	0.20 [0.17, 0.23]

17 End of treatment alkaline phosphatase (U/L) Show forest plot	2	38	Mean Difference (IV, Random, 95% CI)	‐21.81 [‐40.39, ‐3.22]

18 End of treatment CrCl (mL/min) Show forest plot	4	111	Mean Difference (IV, Random, 95% CI)	‐1.68 [‐6.92, 3.56]

19 End of treatment absolute BMD femoral neck (g/cm²) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

20 End of treatment absolute BMD lumbar spine (g/cm²) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

21 Worsening vascular calcification Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

22 Development of vascular calcification Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

23 Withdrawal of treatment due to hypercalcaemia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 1. Vitamin D versus placebo/no treatment

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Comparison 2. Established vitamin D versus placebo/no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	2	202	Risk Ratio (M‐H, Random, 95% CI)	1.49 [0.14, 15.69]

2 Commencement of dialysis Show forest plot	3	246	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.34, 1.63]

3 Fracture Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4 Parathyroidectomy Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5 Improvement in bone histomorphometry Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

6 Development of osteitis fibrosa Show forest plot	2	43	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.23, 1.29]

7 Development of osteomalacia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

8 End of treatment osteoid volume (mm³/cm³) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

9 End of treatment osteoid thickness (µm) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

10 End of treatment parathyroid hormone (pg/mL) Show forest plot	3	98	Mean Difference (IV, Random, 95% CI)	‐54.98 [‐124.37, 14.41]

11 One or more episodes of hypercalcaemia Show forest plot	5	337	Risk Ratio (M‐H, Random, 95% CI)	3.36 [1.14, 9.93]

12 One or more episodes of hyperphosphataemia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

13 One or more episodes of elevated calcium x phosphorus product Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

14 Withdrawal of treatment due to hypercalcaemia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

15 End of treatment serum phosphorus (mg/dL) Show forest plot	2	85	Mean Difference (IV, Random, 95% CI)	0.51 [‐0.19, 1.20]

16 End of treatment serum calcium (mg/dL) Show forest plot	4	129	Mean Difference (IV, Random, 95% CI)	0.20 [0.17, 0.23]

17 End of treatment alkaline phosphatase (U/L) Show forest plot	2	38	Mean Difference (IV, Random, 95% CI)	‐21.81 [‐40.39, ‐3.22]

18 End of treatment CrCl (mL/min) Show forest plot	3	69	Mean Difference (IV, Random, 95% CI)	‐1.95 [‐9.45, 5.54]

19 End of treatment absolute BMD femoral neck (g/cm²) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

20 End of treatment absolute BMD lumbar spine (g/cm²) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

21 Worsening vascular calcification Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

22 Development of vascular calcification Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 2. Established vitamin D versus placebo/no treatment

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Comparison 3. Newer vitamin D versus placebo/no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	2	275	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.16, 7.34]

2 Commencement of dialysis Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Reduction of serum PTH > 30% from baseline value Show forest plot	2	264	Risk Ratio (M‐H, Random, 95% CI)	7.87 [4.87, 12.73]

4 End of treatment parathyroid hormone (pg/mL) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

5 End of treatment serum calcium (mg/dL) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

6 End of treatment serum phosphorus (mg/dL) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

7 One or more episodes of hypercalcaemia Show forest plot	2	275	Risk Ratio (M‐H, Random, 95% CI)	2.15 [0.28, 16.23]

8 One or more episodes of hyperphosphataemia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

9 One or more episodes of elevated calcium x phosphorus product Show forest plot	2	275	Risk Ratio (M‐H, Random, 95% CI)	1.63 [0.57, 4.66]

10 End of treatment CrCl (mL/min) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 3. Newer vitamin D versus placebo/no treatment

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Comparison 4. Intermittent vitamin D versus daily vitamin D

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 One or more episodes of hypercalcaemia Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 4. Intermittent vitamin D versus daily vitamin D

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