Clinical Trials Logo
  1. Home
  2. Iron Deficiency
  3. NCT04949165

Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study — BLIS  

Iron-deficiency Clinical Trial

Official title:
Iron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04949165
Study type Interventional
Source University of Minnesota
Contact
Status Completed
Phase N/A
Start date September 7, 2021
Completion date May 31, 2023
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03218384 - Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency Phase 2
Active, not recruiting NCT03516734 - Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh N/A
Completed NCT03572010 - Stable Iron Isotope Method in HIV+ and HIV- Children N/A
Active, not recruiting NCT03703726 - Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures. N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Not yet recruiting NCT05395468 - Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Not yet recruiting NCT03353662 - Sub Regional Micronutrient Survey in Ethiopia
Completed NCT03819530 - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study N/A
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT03957057 - Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia Phase 3
Completed NCT03642223 - Central and Peripheral Adiposity and Iron Absorption N/A
Not yet recruiting NCT05407987 - Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) Phase 3
Withdrawn NCT03873584 - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Completed NCT04359368 - Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Enrolling by invitation NCT05750940 - Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
Recruiting NCT05126901 - Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years Phase 3
Recruiting NCT05609318 - Imaging Intravenous Iron