drugset / Trial / NCT04435574
Lactoferrin for Treatment of Iron Deficiency Anemia.
RandomizedSingle-groupOpen-labelTreatment
Summary
Anemia is a great public health problem affecting both developing and developed countries. Iron deficiency anemia represents about 50% of causes of anemia worldwide. Lactoferrin fortified milk has a positive effect on Hb and iron status of infants. the hypothesis of this study is "lactoferrin may have comparable efficacy to ferrous sulfate therapy with more tolerability and fewer side effects". the research question of this study is whether oral lactoferrin is effective for treatment of iron deficiency anemia, compared to traditional ferrous sulfate therapy regarding hemoglobin rise and side effects and tolerability.
Timeline
- Start
- 2018-09-05
- Primary completion
- 2019-04-01
- Completion
- 2019-04-01
Publications
- Background Stoltzfus R. Defining iron-deficiency anemia in public health terms: a time for reflection. J Nutr. 2001 Feb;131(2S-2):565S-567S. doi: 10.1093/jn/131.2.565S.
- Background Paesano R, Torcia F, Berlutti F, Pacifici E, Ebano V, Moscarini M, Valenti P. Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant women. Biochem Cell Biol. 2006 Jun;84(3):377-80. doi: 10.1139/o06-040.
- Background Paesano R, Pietropaoli M, Gessani S, Valenti P. The influence of lactoferrin, orally administered, on systemic iron homeostasis in pregnant women suffering of iron deficiency and iron deficiency anaemia. Biochimie. 2009 Jan;91(1):44-51. doi: 10.1016/j.biochi.2008.06.004. Epub 2008 Jun 14.
- Background Rezk M, Dawood R, Abo-Elnasr M, Al Halaby A, Marawan H. Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Fetal Neonatal Med. 2016;29(9):1387-90. doi: 10.3109/14767058.2015.1049149. Epub 2015 Jun 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 6 mg/kg | — |
| Subject | Lactoferrin | Protein / enzyme biologic | 100 mg | Oral |