Clinical trial · Interventional
Folic Acid Clinical Trial for the Prevention of Cervical Cancer
HPV Clearance by Folic Acid Supplementation (FACT for HPV)
NCT00703196CI-TRIAL-00019393completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Supplements, such as folic acid, may stop or delay the development of cervical cancer in women infected with human papillomavirus. PURPOSE: This phase II trial is studying how well folic acid supplements work in preventing cancer in women infected with human papillomavirus.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| folic acid | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
- interventionNames
- Dietary Supplement: folic acid
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Received care at the Health Departments in Alabama and with an abnormal pap result, including any of the following: * Atypical squamous cells of undetermined significance (ASCUS) * ASCUS, cannot exclude high-grade lesion (ASCUS-H) * Low-grade squamous intraepithelial lesion * High-grade squamous intraepithelial lesion * Referred to University of Alabama at Birmingham (UAB) Highlands Clinic for further colposcopic examination by Ob/Gyn physicians * Tested positive for human papilloma virus (HPV) 16 and diagnosed with ≤ cervical intraepithelial neoplasia (CIN) 1 lesions at the 0-month visit * With or without concurrent infections with other HR (High Risk) HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) * Not diagnosed with true preneoplastic lesions of the cervix based on a colposcopically directed biopsy PATIENT CHARACTERISTICS: * Not pregnant * Willing to take study pills, keep scheduled follow-up study visits, or communicate with study personnel about changes in contact information during the study period * No prior diagnosis or treatment for colon polyps or breast lumps PRIOR CONCURRENT THERAPY: * No prior treatment for cervical cancer or precancerous condition * No prior surgeries involving the cervix * No concurrent antifolate medications such as methotrexate, sulfasalazine or phenytoin * No concurrent or planned consumption of 400 μg or more of a folic acid supplement on a regular basis * Not involved in any other clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.