Trial Outcomes & Findings for Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors (NCT NCT00689793)
NCT ID: NCT00689793
Last Updated: 2013-02-15
Results Overview
The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from "no fatigue=0" to "very severe fatigue=10".
COMPLETED
PHASE4
154 participants
baseline and 4 weeks
2013-02-15
Participant Flow
Premopausal female blood donors coming spontaneously to the donation center, were asked to participated to this study. After agreement an informed consent was signed.
One week after whole blood donation, participants were randomized if they were not anemic and their ferritin level was \< or = 30 ng/mL.
Participant milestones
| Measure |
Oral Treatment of Iron
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
One week after donation, donors self-administered on pill of placebo (daily), during one month.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
76
|
|
Overall Study
COMPLETED
|
74
|
71
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Oral Treatment of Iron
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
One week after donation, donors self-administered on pill of placebo (daily), during one month.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors
Baseline characteristics by cohort
| Measure |
Oral Treatment of Iron
n=78 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=76 Participants
One week after donation, donors self-administered on pill of placebo (daily), during one month.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
32.9 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
30.7 years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
31.6 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
78 participants
n=99 Participants
|
76 participants
n=107 Participants
|
154 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksPopulation: The sample size for randomized volunteers was calculated using a two-sample comparison of means to detect a one point difference in the visual analogical scale (first outcome).
The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from "no fatigue=0" to "very severe fatigue=10".
Outcome measures
| Measure |
Oral Treatment of Iron
n=74 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 Participants
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|---|---|---|
|
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
|
3.4 centimeter
Standard Deviation 2.4
|
3.5 centimeter
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: baseline and 4 weeksPopulation: The number of participants was calculated according to the primary outcome.
The level of hemoglobin measured 4 weeks after randomization
Outcome measures
| Measure |
Oral Treatment of Iron
n=74 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 Participants
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|---|---|---|
|
Hemoglobin Variation Before and After Treatment vs Placebo
|
135 g/L
Standard Deviation 6.7
|
130 g/L
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: baseline and 4 weeksLevel of ferritin measured 4 weeks after randomization
Outcome measures
| Measure |
Oral Treatment of Iron
n=74 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 Participants
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|---|---|---|
|
Ferritin Change Before and After 4 Weeks of Treatment/Placebo
|
28.0 ng/mL
Standard Deviation 9.8
|
12.9 ng/mL
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: baseline and 4 weeksSubjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.
Outcome measures
| Measure |
Oral Treatment of Iron
n=74 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 Participants
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|---|---|---|
|
Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test
|
40.5 mLO2/kg/min
Standard Deviation 14.5
|
40.1 mLO2/kg/min
Standard Deviation 17
|
SECONDARY outcome
Timeframe: baseline and 4 weeksPopulation: Number of participant was set according the primary outcome.
Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score \>15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or \<15) after placebo or treatment.
Outcome measures
| Measure |
Oral Treatment of Iron
n=74 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 Participants
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|---|---|---|
|
Response of Iron Supplementation on Mental Disorder
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 4 weeksAdherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)
Outcome measures
| Measure |
Oral Treatment of Iron
n=74 Participants
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 Participants
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|---|---|---|
|
Adherence to Treatment.
|
96 percentage of day
Standard Deviation 16.7
|
96 percentage of day
Standard Deviation 14.2
|
Adverse Events
Oral Treatment of Iron
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Treatment of Iron
n=74 participants at risk
One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
|
Placebo
n=71 participants at risk
One week after donation, donors self-administered on pill of placebo (daily), during one month.
|
|---|---|---|
|
Gastrointestinal disorders
gastro-intestinal events
|
33.8%
25/74 • Number of events 25 • adverse events were reported during the 4 weeks of treatment/placebo
|
15.5%
11/71 • Number of events 11 • adverse events were reported during the 4 weeks of treatment/placebo
|
|
General disorders
other events (not serious)
|
8.1%
6/74 • Number of events 6 • adverse events were reported during the 4 weeks of treatment/placebo
|
4.2%
3/71 • Number of events 3 • adverse events were reported during the 4 weeks of treatment/placebo
|
Additional Information
Dr Bernard Favrat MD
Departement of ambulatory care and community medicine, University of Lausanne, Switzerland
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place