Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2017-10-24
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
Zinc Sulfate 220mg twice daily for three months.
Zinc Sulfate
Participant will take one 220mg tablet twice daily for three months.
Placebo
Gelatin Placebo tablet twice daily for three months.
Placebo (Gelatin Tablet)
Participant will take one tablet twice daily for three months.
Interventions
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Zinc Sulfate
Participant will take one 220mg tablet twice daily for three months.
Placebo (Gelatin Tablet)
Participant will take one tablet twice daily for three months.
Eligibility Criteria
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Inclusion Criteria
* Low-grade squamous intra epithelial lesions (LSIL) on Pap smear OR
* Positive hrHPV on routine screening (positive HPV will be assumed to be high grade)
Exclusion Criteria
* Pregnant patients
* Breastfeeding patients
* Immunocompromised patients
21 Years
65 Years
FEMALE
No
Sponsors
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Spectrum Health Hospitals
OTHER
Responsible Party
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Principal Investigators
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Rebecca Prudnick, DO
Role: PRINCIPAL_INVESTIGATOR
Spectrum Health Hospitals
Locations
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Spectrum Health
Grand Rapids, Michigan, United States
Countries
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References
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de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menendez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andujar M, Castellsague X, Sanchez GI, Nowakowski AM, Bornstein J, Munoz N, Bosch FX; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. Epub 2010 Oct 15.
Franco EL, Villa LL, Sobrinho JP, Prado JM, Rousseau MC, Desy M, Rohan TE. Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a high-risk area for cervical cancer. J Infect Dis. 1999 Nov;180(5):1415-23. doi: 10.1086/315086.
Munoz N, Mendez F, Posso H, Molano M, van den Brule AJ, Ronderos M, Meijer C, Munoz A; Instituto Nacional de Cancerologia HPV Study Group. Incidence, duration, and determinants of cervical human papillomavirus infection in a cohort of Colombian women with normal cytological results. J Infect Dis. 2004 Dec 15;190(12):2077-87. doi: 10.1086/425907. Epub 2004 Nov 22.
Shankar AH, Prasad AS. Zinc and immune function: the biological basis of altered resistance to infection. Am J Clin Nutr. 1998 Aug;68(2 Suppl):447S-463S. doi: 10.1093/ajcn/68.2.447S.
Al-Gurairi FT, Al-Waiz M, Sharquie KE. Oral zinc sulphate in the treatment of recalcitrant viral warts: randomized placebo-controlled clinical trial. Br J Dermatol. 2002 Mar;146(3):423-31. doi: 10.1046/j.1365-2133.2002.04617.x.
Simonart T, de Maertelaer V. Systemic treatments for cutaneous warts: a systematic review. J Dermatolog Treat. 2012 Feb;23(1):72-7. doi: 10.3109/09546634.2010.500324. Epub 2010 Nov 6.
Stefani M, Bottino G, Fontenelle E, Azulay DR. Efficacy comparison between cimetidine and zinc sulphate in the treatment of multiple and recalcitrant warts. An Bras Dermatol. 2009 Jan-Feb;84(1):23-9. doi: 10.1590/s0365-05962009000100003. English, Portuguese.
Kim JH, Bae SN, Lee CW, Song MJ, Lee SJ, Yoon JH, Lee KH, Hur SY, Park TC, Park JS. A pilot study to investigate the treatment of cervical human papillomavirus infection with zinc-citrate compound (CIZAR(R)). Gynecol Oncol. 2011 Aug;122(2):303-6. doi: 10.1016/j.ygyno.2011.04.026. Epub 2011 May 24.
Bulkmans NW, Berkhof J, Bulk S, Bleeker MC, van Kemenade FJ, Rozendaal L, Snijders PJ, Meijer CJ; POBASCAM Study Group. High-risk HPV type-specific clearance rates in cervical screening. Br J Cancer. 2007 May 7;96(9):1419-24. doi: 10.1038/sj.bjc.6603653. Epub 2007 Mar 6.
Nobbenhuis MA, Helmerhorst TJ, van den Brule AJ, Rozendaal L, Voorhorst FJ, Bezemer PD, Verheijen RH, Meijer CJ. Cytological regression and clearance of high-risk human papillomavirus in women with an abnormal cervical smear. Lancet. 2001 Nov 24;358(9295):1782-3. doi: 10.1016/S0140-6736(01)06809-X.
Lopez-Garcia DR, Gomez-Flores M, Arce-Mendoza AY, de la Fuente-Garcia A, Ocampo-Candiani J. Oral zinc sulfate for unresponsive cutaneous viral warts: too good to be true? A double-blind, randomized, placebo-controlled trial. Clin Exp Dermatol. 2009 Dec;34(8):e984-5. doi: 10.1111/j.1365-2230.2009.03623.x. No abstract available.
Fosmire GJ. Zinc toxicity. Am J Clin Nutr. 1990 Feb;51(2):225-7. doi: 10.1093/ajcn/51.2.225.
Molano M, Van den Brule A, Plummer M, Weiderpass E, Posso H, Arslan A, Meijer CJ, Munoz N, Franceschi S; HPV Study Group. Determinants of clearance of human papillomavirus infections in Colombian women with normal cytology: a population-based, 5-year follow-up study. Am J Epidemiol. 2003 Sep 1;158(5):486-94. doi: 10.1093/aje/kwg171.
Raza N, Khan DA. Zinc deficiency in patients with persistent viral warts. J Coll Physicians Surg Pak. 2010 Feb;20(2):83-6.
Miranda PM, Silva NN, Pitol BC, Silva ID, Lima-Filho JL, Carvalho RF, Stocco RC, Becak W, Lima AA. Persistence or clearance of human papillomavirus infections in women in Ouro Preto, Brazil. Biomed Res Int. 2013;2013:578276. doi: 10.1155/2013/578276. Epub 2013 Nov 5.
Other Identifiers
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HPV-Zinc
Identifier Type: -
Identifier Source: org_study_id
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