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NCT04352062

Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

Completed NA Last updated 17 April 2020
What this trial tests

NA trial testing Melatonin in Melatonin Deficiency in 152 participants. Completed in 26 October 2018.

Timeline
9 January 2011
Primary endpoint
26 October 2018
26 October 2018

Quick facts

Lead sponsorMedical University of Lodz
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment152
Start date9 January 2011
Primary completion26 October 2018
Estimated completion26 October 2018
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Lodz

Who can join

Adults 49 to 64, female only, with Melatonin Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration of Helicobacter infection. Methods: The study comprised 152 subjects Including 30 healthy women (group I), 60 women with asymptomatic H.pylori infection (group II), and 64 women H. pylori infected with chronic dyspepsia(group III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia.
    Chojnacki C, Mędrek-Socha M, Konrad P, Chojnacki J, et al · · 2020 · cited 7× · PMID 33243209 · DOI 10.1186/s12905-020-01117-z
  2. The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia
    Chojnacki C, Mędrek-Socha M, Konrad P, Chojnacki J, et al · · 2020 · DOI 10.21203/rs.3.rs-31148/v3

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Other trials of Melatonin

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