Trial Outcomes & Findings for Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study (NCT NCT04949165)
NCT ID: NCT04949165
Last Updated: 2024-07-31
Results Overview
Haemoglobin level at 4 months from the enrollment visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
223 participants
Primary outcome timeframe
4 months
Results posted on
2024-07-31
Participant Flow
Participant milestones
| Measure |
Iron Supplementation
Iron Supplementation: low dose ferrous sulphate (65mg elemental iron) supplements
|
Control
Standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
118
|
|
Overall Study
COMPLETED
|
74
|
56
|
|
Overall Study
NOT COMPLETED
|
31
|
62
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
Baseline characteristics by cohort
| Measure |
Iron Supplementation
n=105 Participants
Iron Supplementation: low dose ferrous sulphate (65mg elemental iron) supplements
|
Control
n=118 Participants
Standard of care
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.70 years
STANDARD_DEVIATION 2.51 • n=99 Participants
|
20.14 years
STANDARD_DEVIATION 3.09 • n=107 Participants
|
19.93 years
STANDARD_DEVIATION 2.83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Akan
|
55 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ewe
|
16 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Dagbani
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ga/Dangbe
|
26 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hausa
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Current student
No
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Current student
Yes
|
102 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
National Blood Service Ghana deferral decision
Deferred
|
40 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
National Blood Service Ghana deferral decision
Not deferred
|
65 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Haemoglobin from FBC (g/dL)
|
11.25 g/dL
STANDARD_DEVIATION 0.91 • n=99 Participants
|
13.39 g/dL
STANDARD_DEVIATION 1.26 • n=107 Participants
|
12.38 g/dL
STANDARD_DEVIATION 1.54 • n=206 Participants
|
|
Ferritin (log(ferritin + 1)
|
3.54 ug/L
STANDARD_DEVIATION 0.87 • n=99 Participants
|
4.21 ug/L
STANDARD_DEVIATION 0.67 • n=107 Participants
|
3.89 ug/L
STANDARD_DEVIATION 0.84 • n=206 Participants
|
|
History of blood loss in the last 3 months
No
|
78 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
History of blood loss in the last 3 months
Yes
|
27 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Siblings with known related anaemia
No
|
104 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Siblings with known related anaemia
Yes
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Heavy, frequent or long duration periods among menstrating women
No
|
40 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Heavy, frequent or long duration periods among menstrating women
Yes
|
37 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Heavy, frequent or long duration periods among menstrating women
Not Applicable (Male or women who are no longer menstruating)
|
28 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Body mass index (kg/mˆ2)
|
24.12 kg/mˆ2
STANDARD_DEVIATION 8.83 • n=99 Participants
|
23.07 kg/mˆ2
STANDARD_DEVIATION 3.31 • n=107 Participants
|
23.57 kg/mˆ2
STANDARD_DEVIATION 6.53 • n=206 Participants
|
|
Systolic blood pressure (mm Hg)
|
116.35 mm Hg
STANDARD_DEVIATION 10.76 • n=99 Participants
|
117.89 mm Hg
STANDARD_DEVIATION 11.08 • n=107 Participants
|
117.17 mm Hg
STANDARD_DEVIATION 10.93 • n=206 Participants
|
|
Diastolic blood pressure (mm Hg)
|
76.17 mm Hg
STANDARD_DEVIATION 7.94 • n=99 Participants
|
76.92 mm Hg
STANDARD_DEVIATION 9.13 • n=107 Participants
|
76.57 mm Hg
STANDARD_DEVIATION 8.58 • n=206 Participants
|
|
Number of meals yesterday
0 (fasting)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of meals yesterday
1 meal
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Number of meals yesterday
2 meals
|
40 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Number of meals yesterday
3 or more meals
|
54 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 monthsHaemoglobin level at 4 months from the enrollment visit.
Outcome measures
| Measure |
Iron Supplementation
n=56 Participants
Iron Supplementation: low dose ferrous sulphate (65mg elemental iron) supplements
|
Control
n=74 Participants
Standard of care
|
|---|---|---|
|
Haemoglobin Level
|
11.35 g/dL
Standard Deviation 1.27
|
12.28 g/dL
Standard Deviation 1.46
|
Adverse Events
Iron Supplementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place