search
Back to results

Zinc Sulfate for Human Papillomavirus (HPV)

Primary Purpose

Human Papilloma Virus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zinc Sulfate
Placebo (Gelatin Tablet)
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Papilloma Virus focused on measuring HPV, ASCUS, LSIL, Cervical Cancer

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Spectrum Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Zinc Sulfate 220mg twice daily for three months.

Gelatin Placebo tablet twice daily for three months.

Outcomes

Primary Outcome Measures

Clearance rates of high risk HPV

Secondary Outcome Measures

Progression versus Regression
Incidence of progression versus regression of cervical changes after treatment with oral zinc sulfate
Side Effects
Rates of side effects from zinc sulfate
Compliance Rates
Examine rates of patients finishing the 3-month course of zinc sulfate
Parity
Examine the correlation of parity on HPV clearance
Low Zinc Levels and Persistence
Examine potential correlation between low serum levels of zinc and persistence of HPV.
Zinc Levels and Regression
Examine the relation between zinc levels before and after treatment and the relation to regression of HPV.

Full Information

First Posted
November 27, 2017
Last Updated
September 21, 2023
Sponsor
Spectrum Health Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT03404310
Brief Title
Zinc Sulfate for Human Papillomavirus (HPV)
Official Title
Oral Zinc Sulfate for the Treatment of High Risk Cervical HPV Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
HPV, ASCUS, LSIL, Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blinded placebo controlled
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Zinc Sulfate 220mg twice daily for three months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Gelatin Placebo tablet twice daily for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc Sulfate
Intervention Description
Participant will take one 220mg tablet twice daily for three months.
Intervention Type
Other
Intervention Name(s)
Placebo (Gelatin Tablet)
Intervention Description
Participant will take one tablet twice daily for three months.
Primary Outcome Measure Information:
Title
Clearance rates of high risk HPV
Time Frame
During 3 month treatment period
Secondary Outcome Measure Information:
Title
Progression versus Regression
Description
Incidence of progression versus regression of cervical changes after treatment with oral zinc sulfate
Time Frame
During 3 month treatment period
Title
Side Effects
Description
Rates of side effects from zinc sulfate
Time Frame
After 3 month treatment period
Title
Compliance Rates
Description
Examine rates of patients finishing the 3-month course of zinc sulfate
Time Frame
After 3 month treatment period
Title
Parity
Description
Examine the correlation of parity on HPV clearance
Time Frame
After 3 month treatment period
Title
Low Zinc Levels and Persistence
Description
Examine potential correlation between low serum levels of zinc and persistence of HPV.
Time Frame
After 3 month treatment period
Title
Zinc Levels and Regression
Description
Examine the relation between zinc levels before and after treatment and the relation to regression of HPV.
Time Frame
After 3 month treatment period

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization) Pregnant patients Breastfeeding patients Immunocompromised patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Prudnick, DO
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20952254
Citation
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.
Results Reference
background
PubMed Identifier
10515798
Citation
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.
Results Reference
background
PubMed Identifier
15551205
Citation
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.
Results Reference
background
PubMed Identifier
9701160
Citation
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.
Results Reference
background
PubMed Identifier
11952542
Citation
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.
Results Reference
background
PubMed Identifier
21054194
Citation
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.
Results Reference
background
PubMed Identifier
19377755
Citation
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.
Results Reference
background
PubMed Identifier
21605892
Citation
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.
Results Reference
background
PubMed Identifier
17342094
Citation
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.
Results Reference
background
PubMed Identifier
11734239
Citation
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.
Results Reference
background
PubMed Identifier
20055878
Citation
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.
Results Reference
background
PubMed Identifier
2407097
Citation
Fosmire GJ. Zinc toxicity. Am J Clin Nutr. 1990 Feb;51(2):225-7. doi: 10.1093/ajcn/51.2.225.
Results Reference
background
PubMed Identifier
12936904
Citation
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.
Results Reference
background
PubMed Identifier
20378032
Citation
Raza N, Khan DA. Zinc deficiency in patients with persistent viral warts. J Coll Physicians Surg Pak. 2010 Feb;20(2):83-6.
Results Reference
background
PubMed Identifier
24298551
Citation
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.
Results Reference
background

Learn more about this trial

Zinc Sulfate for Human Papillomavirus (HPV)

We'll reach out to this number within 24 hrs