drugset / Trial / NCT00364104
Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children
Phase 3
Completed
125 enrolled
The University of Texas Health Science Center, Houston
Baylor College of Medicine · collabTexas Tech University · collabUniversity of North Texas Health Science Center · collabUniversity of Texas · collab
RandomizedFactorialTriple-blindPrevention
Summary
The investigators hypothesize that the Helicobacter pylori bacterium decreases iron from the stomach and that this effect of the infection can be identified among persons with iron deficiency as well as among persons with normal iron stores. The aim of this study is to determine whether Helicobacter pylori eradication in children is followed by an increase in markers of iron stores after six to twelve months of treatment.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Missed primary endpoint
paper no differences across study arms in changes of iron stores. PMID 21336159 ↗
paper we found no effect of H pylori eradication regarding changes in iron stores. PMID 21336159 ↗
Publications
- Cardenas VM, Prieto-Jimenez CA, Mulla ZD, Rivera JO, Dominguez DC, Graham DY, Ortiz M. Helicobacter pylori eradication and change in markers of iron stores among non-iron-deficient children in El Paso, Texas: an etiologic intervention study. J Pediatr Gastroenterol Nutr. 2011 Mar;52(3):326-32. doi: 10.1097/MPG.0b013e3182054123.
- Prieto-Jimenez CA, Cardenas VM, Fischbach LA, Mulla ZD, Rivera JO, Dominguez DC, Graham DY, Ortiz M. Double-blind randomized trial of quadruple sequential Helicobacter pylori eradication therapy in asymptomatic infected children in El Paso, Texas. J Pediatr Gastroenterol Nutr. 2011 Mar;52(3):319-25. doi: 10.1097/MPG.0b013e318206870e.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferrous Sulfate | Diagnostic / imaging agent | — | — |