Hypoferritinemia Without Anemia Among Reproductive Age Females
Summary
The goal of this randomized controlled trial is to compare the treatment outcomes of oral iron supplementation (Group A) versus Intravenous (IV) iron supplementation (Group B) versus no treatment (Group C) on the serum ferritin level and to determine the outcomes in the severity of symptoms of HWA, among reproductive age females (age 18-45) with hypoferritinemia without Anemia (HWA), after four months of the start of the intervention. Participants will: * Randomly divided into 3 groups (A, B and C) to receive treatment. * 100 patients will be allocated to each of the three study groups i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will get no treatment.
Timeline
- Start
- 2022-10-10
- Primary completion
- 2025-10-16
- Completion
- 2025-10-16
Publications
- Background Abuaisha M, Itani H, El Masri R, Antoun J. Prevalence of Iron Deficiency (ID) without anemia in the general population presenting to primary care clinics: a cross-sectional study. Postgrad Med. 2020 Apr;132(3):282-287. doi: 10.1080/00325481.2020.1715701. Epub 2020 Jan 22.
- Background Adams J, White M. Characterisation of UK diets according to degree of food processing and associations with socio-demographics and obesity: cross-sectional analysis of UK National Diet and Nutrition Survey (2008-12). Int J Behav Nutr Phys Act. 2015 Dec 18;12:160. doi: 10.1186/s12966-015-0317-y.
- Background Al-Jafar HA. HWA: Hypoferritinemia without anemia a hidden hematology disorder. J Family Med Prim Care. 2017 Jan-Mar;6(1):69-72. doi: 10.4103/2249-4863.214986.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric carboxymaltose | Other / unclassified | 50 mg/ml | Intravenous |
| Comparator | Iron III Hydroxide Polymaltose Complex | Unknown | 100 mg | Oral |