Trial Outcomes & Findings for Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate (NCT NCT01991314)
NCT ID: NCT01991314
Last Updated: 2017-05-09
Results Overview
Change in serum Hb concentration in g/dl after 6 weeks of oral iron
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Baseline (0 weeks) and end of trial (6 weeks)
Results posted on
2017-05-09
Participant Flow
Between January 2012 and April 2015; adult and paediatric IBD clinics at Barts and the Royal London Hospitals, or the paediatric IBD clinic at Chelsea and Westminster NHS Trust, London, UK, w
After trial closure, 1 adult (transferrin saturation 22%) and 1 adolescent (Hb 12.0) were found to have been recruited in error and were excluded from further analysis, leaving 88 participants in total.
Participant milestones
| Measure |
Adolescents - Ferrous Sulphate
45 adolescents (13-18 years) given ferrous sulphate 200mg bd for 6 weeks
|
Adults - Ferrous Sulphate
43 adults (\>18 years) given ferrous sulphate 200mg bd for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
Adolescents - Ferrous Sulphate
45 adolescents (13-18 years) given ferrous sulphate 200mg bd for 6 weeks
|
Adults - Ferrous Sulphate
43 adults (\>18 years) given ferrous sulphate 200mg bd for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
Baseline Characteristics
Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate
Baseline characteristics by cohort
| Measure |
Adolescent - Ferrous Sulphate
n=45 Participants
45 adolescents (age 13-18 years) given oral ferrous sulphate 200mg bd for 6 weeks
|
Adults - Ferrous Sulphate
n=43 Participants
43 adults (age \>18 years) given oral ferrous sulphate 200mg bd for 6 weeks
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
45 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
45 participants
n=5 Participants
|
43 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 weeks) and end of trial (6 weeks)Population: Intention to treat population
Change in serum Hb concentration in g/dl after 6 weeks of oral iron
Outcome measures
| Measure |
Adolescents
n=45 Participants
Patients aged 13 - 18 years
|
Adults
n=43 Participants
IBD patients aged \>18
|
|---|---|---|
|
Mean Change in Haemoglobin Concentration.
|
1.22 g/dl
Standard Error 0.21
|
1.30 g/dl
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline (0 weeks) to end of trial (6 weeks)Numbers of patients who reported intolerance of oral iron (abdominal pain, nausea, vomiting, constipation, diarrhoea or headache)
Outcome measures
| Measure |
Adolescents
n=45 Participants
Patients aged 13 - 18 years
|
Adults
n=43 Participants
IBD patients aged \>18
|
|---|---|---|
|
Intolerance of Oral Iron
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline (0 weeks) and end of trial (6 weeks)Population: Per protocol analysis
Difference between faecal calprotectin measured at baseline and at end of study
Outcome measures
| Measure |
Adolescents
n=34 Participants
Patients aged 13 - 18 years
|
Adults
n=32 Participants
IBD patients aged \>18
|
|---|---|---|
|
Change in Disease Activity (Stool Calprotectin)
|
-35 ug/g
Standard Error 38
|
-40 ug/g
Standard Error 81
|
SECONDARY outcome
Timeframe: Baseline (0 weeks) to end (6 weeks)Population: Per protocol analysis
Short Inflammatory Bowel Disease Questionnaire (SIBDQ score), a health-related quality of life tool measuring physical, social, and emotional status (summated to produce a score of minimum 10 to maximum 70, representing poor to good quality of life, respectively). (Reporting of individual domain subscores is not valid).
Outcome measures
| Measure |
Adolescents
n=34 Participants
Patients aged 13 - 18 years
|
Adults
n=32 Participants
IBD patients aged \>18
|
|---|---|---|
|
Change in Quality of Life Score
|
3.2 scores on a scale
Standard Error 2.6
|
5.7 scores on a scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline (0 weeks) and end of trial (6 weeks)Population: Per protocol
Hospital Anxiety and Depression Score (HADS)-A, a scale of 7 questions score 0-3 each, so that total score 0 is good and 21 very severe anxiety.
Outcome measures
| Measure |
Adolescents
n=34 Participants
Patients aged 13 - 18 years
|
Adults
n=32 Participants
IBD patients aged \>18
|
|---|---|---|
|
Changes in Anxiety
|
-0.7 units on a scale
Standard Error 0.5
|
-1.1 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline (0 weeks) and end of trial (6 weeks)Population: Per protocol
Multidimensional Fatigue Inventory (MFI) is a 20 question-based scale with total scores ranging between 20 (very good) and 100 (very severe fatigue).
Outcome measures
| Measure |
Adolescents
n=34 Participants
Patients aged 13 - 18 years
|
Adults
n=32 Participants
IBD patients aged \>18
|
|---|---|---|
|
Changes in Fatigue
|
0.9 units on a scale
Standard Error 1.4
|
1.9 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline (0 weeks) and end of trial (6 weeks)Population: Per protocol analysis
Perceived Stress Questionnaire (PSQ)-G is a 30-question measure of perceived stress giving total scores ranging between 30 (very unstressed) to 120 (very stressed).
Outcome measures
| Measure |
Adolescents
n=34 Participants
Patients aged 13 - 18 years
|
Adults
n=32 Participants
IBD patients aged \>18
|
|---|---|---|
|
Changes in Stress Levels
|
4.1 units on a scale
Standard Error 2.5
|
-11.8 units on a scale
Standard Error 2.5
|
Adverse Events
Adolescents
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Adults
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adolescents
n=45 participants at risk
Patients aged 13 - 18 years
|
Adults
n=43 participants at risk
IBD patients aged \>18
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's patient admitted to hospital with abdominal pain and vomiting
|
2.2%
1/45 • Number of events 1 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
0.00%
0/43 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
|
Gastrointestinal disorders
Crohn's patient admitted to hospital with abdominal pain, vomiting and constipation
|
2.2%
1/45 • Number of events 1 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
0.00%
0/43 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
|
Gastrointestinal disorders
Ulcerative colitis patient admitted with flare of her colitis
|
0.00%
0/45 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
2.3%
1/43 • Number of events 1 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
Other adverse events
| Measure |
Adolescents
n=45 participants at risk
Patients aged 13 - 18 years
|
Adults
n=43 participants at risk
IBD patients aged \>18
|
|---|---|---|
|
Gastrointestinal disorders
AE
|
17.8%
8/45 • Number of events 8 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
16.3%
7/43 • Number of events 7 • Baseline (0 weeks) to end of trial (6 weeks)
Patients were asked to contact us by telephone if they had symptoms suggesting adverse events (eg abdominal pain, nausea, vomiting, constipation, diarrhea, headache), or if their Crohn's disease or ulcerative colitis symptoms were worsening. Patients described their own symptoms and were not prompted by a checklist or other systematic questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place