Anaemia Clinical Trial
Official title:
The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.
Fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. Questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. They are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. Isotope studies have shown that even in the presence of phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in South Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-Saharan Africa. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05682326 -
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
|
Phase 3 | |
Completed |
NCT03400033 -
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
|
Phase 3 | |
Completed |
NCT02879305 -
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
|
Phase 3 | |
Completed |
NCT02876835 -
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
|
Phase 3 | |
Terminated |
NCT02801162 -
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
|
N/A | |
Completed |
NCT02288637 -
Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product
|
N/A | |
Completed |
NCT00276224 -
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
|
N/A | |
Completed |
NCT00857077 -
Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana
|
N/A | |
Completed |
NCT06080555 -
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
|
Phase 1 | |
Completed |
NCT01977573 -
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
|
Phase 2 | |
Completed |
NCT02243306 -
Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
|
Phase 1 | |
Completed |
NCT01111630 -
Study of Erythropoietin (EPO) Administration Schedule
|
Phase 4 | |
Completed |
NCT00140517 -
Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance
|
N/A | |
Completed |
NCT03239522 -
Absorption and Elimination of Radiolabeled Daprodustat
|
Phase 1 | |
Completed |
NCT01376232 -
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
|
Phase 1 | |
Completed |
NCT02019719 -
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT02969655 -
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02637102 -
The UK CAVIAR Study
|
||
Completed |
NCT01454752 -
Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
|
N/A | |
Completed |
NCT01136850 -
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
|
Phase 3 |