Table 3 Safety outcomes by allocation

From: High-dose vitamin D3 to improve outcomes in the convalescent phase of complicated severe acute malnutrition in Pakistan: a double-blind randomised controlled trial (ViDiSAM)

  

Placebo (n = 129)a

Vitamin D (n = 127)b

  

No. of events

Proportion of participants with one or more events (%)

No. of events

Proportion of participants with one or more events (%)

Fatal serious adverse eventc

 

2

2/128 (1.6)

0

0/123 (0.0)

Non-fatal serious adverse eventc

 

9

9/128 (7.0)

3

3/123 (2.4)

Non-serious adverse event leading to discontinuation of study supplement

 

0

0/128 (0.0)

0

0/123 (0.0)

Relapse of SAM (complicated or uncomplicated)

 

4

4/128 (3.1)

3

3/123 (2.4)

Other monitored safety conditions

Hypercalcaemiad

6

5/128 (3.9)

2

2/123 (1.6)

Hypervitaminosis De

1

1/83 (1.2)

22

22/85 (25.9)

Hypercalciuriaf

56

50/128 (39.1)

51

44/123 (35.8)

  1. ano. of participants who took at least one dose of placebo and for whom follow-up data were available for at least one timepoint.
  2. bno. of participants who took at least one dose of vitamin D and for whom follow-up data were available for at least one timepoint.
  3. ccauses for each event presented in Table S5, Supplementary Information.
  4. ddefined as serum albumin-adjusted calcium concentration >2.65 mmol/L.
  5. edefined as 25(OH)D concentration >220 nmol/L.
  6. edefined as urinary calcium:creatinine molar ratio >1.00.