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Human Papilloma VirusNCT03404310

Zinc Sulfate for Human Papillomavirus (HPV)

A study testing Zinc Sulfate in people with Human Papilloma Virus, run by Corewell Health West at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The Human Papillomavirus (HPV) is well established as the primary causative agent in both warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous… Read more about this study

Who is it for?
Ages 21 to 65 years, women only
Conditions the study is for
Human Papilloma Virus
What is being tested?
Zinc Sulfate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
24 Oct 2017to 28 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Abnormal cytology of atypical squamous cells of undetermined significance (ASCUS) on Pap smear OR
  • 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)

Who cannot join

  • Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization)
  • Pregnant patients
  • Breastfeeding patients
  • Immunocompromised patients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Spectrum Health

    Grand Rapids, Michigan, 49503

Other trials in United States

About this study

Official title: Oral Zinc Sulfate for the Treatment of High Risk Cervical HPV Versus Placebo

The Human Papillomavirus (HPV) is well established as the primary causative agent in both warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous lesions. Zinc has been shown to play a central role in immunity. This study is to determine if oral zinc sulfate can improve clearance rates of high risk HPV versus placebo.

Read the detailed description

Upon enrollment eligible participants will be randomized and given a three-month supply of zinc sulfate or placebo to be taken as directed. They will have zinc serum lab testing at enrollment and upon study completion. Patients will also be asked to complete short questionnaires and to make study staff aware of any side effects they should experience.

Being tested
Zinc Sulfate, Placebo (Gelatin Tablet)
Keywords
HPV, ASCUS, LSIL, Cervical Cancer
Medical subject headings
Atypical Squamous Cells of the Cervix, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zinc SulfateDietary supplement

    Participant will take one 220mg tablet twice daily for three months.

  • Placebo (Gelatin Tablet)Other

    Participant will take one tablet twice daily for three months.

Study groups in NCT03404310
Study groupRoleWhat they receive
TreatmentExperimentalZinc Sulfate 220mg twice daily for three months.
Receives: Dietary Supplement: Zinc Sulfate
PlaceboPlacebo comparatorGelatin Placebo tablet twice daily for three months.
Receives: Other: Placebo (Gelatin Tablet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clearance rates of high risk HPV

    Measured: During 3 month treatment period

Secondary outcomes (6)

  1. Progression versus Regression

    Incidence of progression versus regression of cervical changes after treatment with oral zinc sulfate

    Measured: During 3 month treatment period

  2. Side Effects

    Rates of side effects from zinc sulfate

    Measured: After 3 month treatment period

  3. Compliance Rates

    Examine rates of patients finishing the 3-month course of zinc sulfate

    Measured: After 3 month treatment period

  4. Parity

    Examine the correlation of parity on HPV clearance

    Measured: After 3 month treatment period

  5. Low Zinc Levels and Persistence

    Examine potential correlation between low serum levels of zinc and persistence of HPV.

    Measured: After 3 month treatment period

  6. Zinc Levels and Regression

    Examine the relation between zinc levels before and after treatment and the relation to regression of HPV.

    Measured: After 3 month treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start24 Oct 2017
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

Why it stopped: Lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404310
Sponsor's protocol ID
HPV-Zinc
Status last verified
Sep 2023
First submitted
27 Nov 2017
Last updated
22 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20952254

  • 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.

    PubMed 10515798

  • 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.

    PubMed 15551205

  • 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.

    PubMed 9701160

  • 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.

    PubMed 11952542

  • 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.

    PubMed 21054194

  • 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.

    PubMed 19377755

  • 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.

    PubMed 21605892

  • 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.

    PubMed 17342094

  • 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.

    PubMed 11734239

  • 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.

    PubMed 20055878

  • Fosmire GJ. Zinc toxicity. Am J Clin Nutr. 1990 Feb;51(2):225-7. doi: 10.1093/ajcn/51.2.225.

    PubMed 2407097

  • 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.

    PubMed 12936904

  • Raza N, Khan DA. Zinc deficiency in patients with persistent viral warts. J Coll Physicians Surg Pak. 2010 Feb;20(2):83-6.

    PubMed 20378032

  • 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.

    PubMed 24298551

Questions about this trial

What is this clinical trial studying?

A study testing Zinc Sulfate in people with Human Papilloma Virus, run by Corewell Health West at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance rates of high risk HPV (time frame: During 3 month treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404310, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.

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