ClinicalTrials.gg
TerminatedNCT03404310Updated Sep 22, 2023

Zinc Sulfate for Human Papillomavirus (HPV)

An interventional study of Zinc Sulfate and Placebo (Gelatin Tablet) in Human Papilloma Virus, sponsored by Spectrum Health Hospitals. Terminated at 1 site in United States. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Spectrum Health Hospitals · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of recruitment

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Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Atypical Squamous Cells of the Cervix with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Atypical Squamous Cells of the Cervix · United States.

Enrollment
10th of 12
21 · median 163
Started
2017
the only one that year
No phase
4 of 13
none open now
Registered
11th of 13
by date
Lead sponsor
1 of 13
Spectrum Health Hospitals

Among the 13 studies in Atypical Squamous Cells of the Cervix with a site in United States, this one is the 10th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2017, is one of 4 with no phase, and was the 11th registered.

Atypical Squamous Cells of the Cervix

28 studies on the registry are indexed under Atypical Squamous Cells of the Cervix; 4 are open to participants now.

Browse Atypical Squamous Cells of the Cervix studies →

Open to participants now

1 of the 13 studies in Atypical Squamous Cells of the Cervix with a site in United States is open now. Recruiting first, the newest first:

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 3 Atypical Squamous Cells of the Cervix studies recruiting now, 1 sets no upper age limit and 1 stops at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 21 Years to 65 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Atypical Squamous Cells of the Cervix with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Human Papilloma Virus

Keywords

  • HPV
  • ASCUS
  • LSIL
  • Cervical Cancer
04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization)
  • Pregnant patients
  • Breastfeeding patients
  • patients
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Treatment

    Zinc Sulfate 220mg twice daily for three months.

    Dietary Supplement: Zinc Sulfate

  • Placebo comparator
    Placebo

    Gelatin Placebo tablet twice daily for three months.

    Other: Placebo (Gelatin Tablet)

Interventions

  • Dietary supplementZinc Sulfate

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

  • OtherPlacebo (Gelatin Tablet)

    Participant will take one tablet twice daily for three months.

06

What researchers measure

Primary outcomes

  1. Clearance rates of high risk HPV

    Time frame: During 3 month treatment period

Secondary outcomes

  1. Progression versus Regression

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

    Time frame: During 3 month treatment period

  2. Side Effects

    Rates of side effects from zinc sulfate

    Time frame: After 3 month treatment period

  3. Compliance Rates

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

    Time frame: After 3 month treatment period

  4. Parity

    Examine the correlation of parity on HPV clearance

    Time frame: After 3 month treatment period

  5. Low Zinc Levels and Persistence

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

    Time frame: 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.

    Time frame: After 3 month treatment period

07

Study locations

1 site
  • Spectrum Health
    Grand Rapids, Michigan 49503, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Jun 2019, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Jan 19, 2018
StartActual
Oct 24, 2017
Primary completionActual
Jun 28, 2019
CompletionActual
Jun 28, 2019
Last update
Sep 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03404310
Lead sponsor
Spectrum Health Hospitals
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Oct 24, 2017
Primary completion
Jun 28, 2019
Completion
Jun 28, 2019
Last update
Sep 22, 2023

Study contacts

Rebecca Prudnick, DO
principal investigator · Spectrum Health Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Zinc Sulfate

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