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Table 3 Undesirable events, compliance, and blinding.

From: Clinical evaluation of iron treatment efficiency among non-anemic but iron-deficient female blood donors: a randomized controlled trial

 

FeSO4

n = 74

Placebo

n = 71

Absolute difference

Significance level

Fisher's exact test

Undesirable events, n (%)

    

   Hard stools

13 (17.6%)

3 (4.2%)

13.4%

P = 0.015

   Liquid stools

9 (12.2%)

3 (4.2%)

8.0%

P = 0.130

   Abdominal pain

7 (9.5%)

4 (5.6%)

3.9%

P = 0.534

   Nausea

2 (2.7%)

0 (0%)

2.7%

P = 0.497

   Any gastrointestinal

25 (33.8%)

8 (11.3%)

22.5%

P = 0.001

   Other events

6 (8.1%)

3 (4.2%)

3.9%

P = 0.495

   Any event

29 (39.2%)

11 (15.5%)

23.7%

P = 0.002

Days with correct dosing (compliance)a

    

   Mean (SD)

26.3 (3.9)

26.5 (2.8)

-0.2

P = 0.624

   Median (range)

27 (7 to 35)

27 (13 to 35)

0

 

Believed to have received b n (%)

    

   FeSO4

44 (60.3%)

9 (12.9%)

37.4%

P < 0.001

   Placebo

13 (18.8%)

42 (60.0%)

41.2%

 

   Does not know

16 (21.9%)

19 (27.1%)

5.2%

 
  1. aThe container with remaining pills was not returned by two donors from the control group. bOne patient from the intervention group did not answer.