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Table 2 Outcomes in iron and placebo groups after four weeks of treatment.

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

 

FeSO4

Placebo

Treatment effecta

 

n = 74

mean (SD)

n = 71

mean (SD)

Crude ITT group difference

Δ (95%CI)

Significance level

LR test

Adjusted effectb

Δ (CI95%)

Visual analogue scale fatigue

3.4 (2.4)

3.5 (2.5)

-0.15 (-0.9 to 0.6)

P = 0.697

-0.18 (-0.9 to 0.6)

Fatigue severity scalec

2.5 (1.3)

2.6 (1.5)

-0.06 (-0.4 to 0.3)

P = 0.760

-0.05 (-0.4 to 0.3)

Vitality item (SF-12V2)d

53.6 (12.7)

55.3 (12.3)

-0.24 (-3.9 to 3.4)

P = 0.897

-0.13 (-3.8 to 3.6)

Chester step test, mLO2/kg/minc

40.5 (14.5)

40.1 (17.0)

0.28 (-4.5 to 5.1)

P = 0.907

0.02 (-4.8 to 4.8)

Hemoglobin, g/L

135 (6.7)

130 (5.3)

5.2 (3.5 to 6.9)

P < 0.001

5.3 (3.7 to 7.0)

Ferritin, ng/mL

28.0 (9.8)

12.9 (8.3)

14.8 (12.2 to 17.4)

P < 0.001

15.1 (12.6 to 17.6)

Quality of life (SF-12NL)e

     

   Physical condition

54.8 (3.3)

52.4 (5.2)

2.4 (1.1 to 3.7)

P < 0.001

2.4 (1.1 to 3.7)

   Mental health

40.1 (4.8)

40.7 (4.8)

-0.4 (-2.0 to 1.2)

P = 0.590

-0.5 (-2.0 to 1.1)

  1. aTreatment effect was measured using linear regression, with treatment group and baseline value of fatigue as independent variables. bWas adjusted for baseline imbalance for menstrual bleeding. cData were missing for one donor from the control group. dTwo donors from the intervention group and four donors from the control did not answer question 10 from the SF-12V2. eSF-12 was not completed by nine donors from the intervention group and three from the control. CI: confidence interval; ITT: intention to treat analysis; LR: likelihood ratio.