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NCT04352062
Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia
NA trial testing Melatonin in Melatonin Deficiency in 152 participants. Completed in 26 October 2018.
26 October 2018
Quick facts
| Lead sponsor | Medical University of Lodz |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 152 |
| Start date | 9 January 2011 |
| Primary completion | 26 October 2018 |
| Estimated completion | 26 October 2018 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Melatonin (MELATONIN) — full drug profile →
- placebo
- Pantoprazole 40mg — full drug profile →
- Amoxicillin (amoxicillin) — full drug profile →
- Levofloxacin 500mg — full drug profile →
Conditions studied
- Melatonin Deficiency — all drugs for Melatonin Deficiency →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT04352062
- Europe PMC full search
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Related trials
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- NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
- NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting
Other Medical University of Lodz trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04352062 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Lodz
- Last refreshed: 17 April 2020
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