Iron-deficiency Clinical Trial
Official title:
A Randomised, Double-blind Study to Determine the Safety and Efficacy of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks.
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks. IHAT is a novel bioavailable source of iron. It is a tartrate-modified, nanoparticulate ferric oxo-hydroxide with similar functional properties and small primary particle size to the iron form found in the ferritin core (ferrihydrite). In this trial, subjects will be randomly assigned to receive either (1) IHAT once a day, (2) IHAT twice a day or (3) a placebo daily for 12 weeks. The primary endpoint is the correction of iron deficiency at week 12. Secondary endpoints include iron status, iron deficiency symptoms and gastrointestinal symptoms over the course of the 12 weeks. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04949165 -
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
|
N/A | |
| 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| Withdrawn |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 |