Iron-deficiency, Iron-deficiency Anemia
Conditions
Keywords
Blood donation
Brief summary
This pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (ID) and iron deficiency anaemia (IDA) among first-time donors, and 2) a longitudinal 2-arm parallel groups trial among first- time voluntary donors that compares haemoglobin levels at 4 months among those with ID or IDA who receive iron supplementation to those without ID or IDA who do not receive iron supplementation. A structured questionnaire will be used to extract demographic characteristics. Participants will be followed for a total of 6 months with study visits at 2, 4 and 6 months after the baseline assessments. Blood draws for full blood count (FBC), peripheral film comment, malaria rapid diagnostic tests (RDT) and ferritin assessment will occur at baseline and all follow-up visits. In addition, we will use a qualitative approach to identify barriers and facilitators of blood donation and the use of dietary and iron supplementation strategies to address iron deficiency and/or anaemia. This will involve conducting focus group discussions during the last month of the intervention and key informant interviews. Expected Outcomes The expected outcomes of the study have been grouped into two, primary and secondary. Primary Outcome will be haemoglobin level after 4 months. Secondary Outcomes are A. Change in haemoglobin levels B. Diagnosis of ID or IDA at 4 months C. Serum ferritin concentration after 4 months of intervention D. Acceptability of iron supplementation among participants and stakeholders E. Incidence of gastrointestinal adverse events F. Incidence of suspected malaria or bacterial infections G. Incidence of ID and IDA H. Successful return (non-deferred) to the blood donor pool after intervention within 6 months of enrolment I. Key barriers and facilitators of intervention implementation.
Interventions
DIETARY_SUPPLEMENTIron Supplementation
low dose ferrous sulphate (65mg elemental iron) supplements
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Blood Service Ghana
University of Ghana Medical School
Liverpool School of Tropical Medicine
Syracuse University
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females aged between 17 and 60 years who weigh at least 50kg. * Pass pre-donation screening using the NBSG standardised donor screening questionnaire for medical conditions and lifestyle risks for transfusion transmissible infections * Vital signs must meet the NBSG requirement for blood donation: systolic and diastolic blood pressures between 90-140 mmHg and 60- 90 mmHg, respectively; pulse rate between 50-100 bpm; non-contact forehead temperature not exceeding 37.5°C; meeting acceptable requirements for skin lesions, needle marks and physical appearance. * Must be willing and able to give study consent or assent. * Intend to remain in the study location/site during the entire length of the study.
Exclusion criteria
* Persons who have used iron supplementation within the past one month. * Participant reports having previously donated blood. * Evidence for a TTI at baseline among those who successfully donated. * Evidence of Malaria and helminthic infections at baseline * Participants who have Hb \<10g/dl at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin Level | 4 months | Haemoglobin level at 4 months from the enrollment visit. |
Countries
Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iron Supplementation Iron Supplementation: low dose ferrous sulphate (65mg elemental iron) supplements | 105 |
| Control Standard of care | 118 |
| Total | 223 |
Baseline characteristics
| Characteristic | Total | Iron Supplementation | Control |
|---|---|---|---|
| Age, Continuous | 19.93 years STANDARD_DEVIATION 2.83 | 19.70 years STANDARD_DEVIATION 2.51 | 20.14 years STANDARD_DEVIATION 3.09 |
| Body mass index (kg/mˆ2) | 23.57 kg/mˆ2 STANDARD_DEVIATION 6.53 | 24.12 kg/mˆ2 STANDARD_DEVIATION 8.83 | 23.07 kg/mˆ2 STANDARD_DEVIATION 3.31 |
| Current student No | 5 Participants | 3 Participants | 2 Participants |
| Current student Yes | 218 Participants | 102 Participants | 116 Participants |
| Diastolic blood pressure (mm Hg) | 76.57 mm Hg STANDARD_DEVIATION 8.58 | 76.17 mm Hg STANDARD_DEVIATION 7.94 | 76.92 mm Hg STANDARD_DEVIATION 9.13 |
| Ferritin (log(ferritin + 1) | 3.89 ug/L STANDARD_DEVIATION 0.84 | 3.54 ug/L STANDARD_DEVIATION 0.87 | 4.21 ug/L STANDARD_DEVIATION 0.67 |
| Haemoglobin from FBC (g/dL) | 12.38 g/dL STANDARD_DEVIATION 1.54 | 11.25 g/dL STANDARD_DEVIATION 0.91 | 13.39 g/dL STANDARD_DEVIATION 1.26 |
| Heavy, frequent or long duration periods among menstrating women No | 77 Participants | 40 Participants | 37 Participants |
| Heavy, frequent or long duration periods among menstrating women Not Applicable (Male or women who are no longer menstruating) | 84 Participants | 28 Participants | 56 Participants |
| Heavy, frequent or long duration periods among menstrating women Yes | 62 Participants | 37 Participants | 25 Participants |
| History of blood loss in the last 3 months No | 156 Participants | 78 Participants | 78 Participants |
| History of blood loss in the last 3 months Yes | 67 Participants | 27 Participants | 40 Participants |
| National Blood Service Ghana deferral decision Deferred | 43 Participants | 40 Participants | 3 Participants |
| National Blood Service Ghana deferral decision Not deferred | 180 Participants | 65 Participants | 115 Participants |
| Number of meals yesterday 0 (fasting) | 1 Participants | 1 Participants | 0 Participants |
| Number of meals yesterday 1 meal | 16 Participants | 10 Participants | 6 Participants |
| Number of meals yesterday 2 meals | 87 Participants | 40 Participants | 47 Participants |
| Number of meals yesterday 3 or more meals | 119 Participants | 54 Participants | 65 Participants |
| Race/Ethnicity, Customized Akan | 112 Participants | 55 Participants | 57 Participants |
| Race/Ethnicity, Customized Dagbani | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Ewe | 44 Participants | 16 Participants | 28 Participants |
| Race/Ethnicity, Customized Ga/Dangbe | 45 Participants | 26 Participants | 19 Participants |
| Race/Ethnicity, Customized Hausa | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Female | 140 Participants | 79 Participants | 61 Participants |
| Sex: Female, Male Male | 83 Participants | 26 Participants | 57 Participants |
| Siblings with known related anaemia No | 221 Participants | 104 Participants | 117 Participants |
| Siblings with known related anaemia Yes | 2 Participants | 1 Participants | 1 Participants |
| Systolic blood pressure (mm Hg) | 117.17 mm Hg STANDARD_DEVIATION 10.93 | 116.35 mm Hg STANDARD_DEVIATION 10.76 | 117.89 mm Hg STANDARD_DEVIATION 11.08 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 118 |
| other Total, other adverse events | 0 / 105 | 0 / 118 |
| serious Total, serious adverse events | 0 / 105 | 0 / 118 |
Outcome results
Primary
Haemoglobin Level
Haemoglobin level at 4 months from the enrollment visit.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iron Supplementation | Haemoglobin Level | 11.35 g/dL | Standard Deviation 1.27 |
| Control | Haemoglobin Level | 12.28 g/dL | Standard Deviation 1.46 |
p-value: 0.025t-test, 1 sided