Effect of supplementation in treatment of women with cervical intraepithelial neoplasia 2 and 3

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2017021417639N2
• Date of registration: 2017-02-27
• Prospective Registration: No
• Primary sponsor: Vice chancellor for research, Isfahan University of Medical Science
• Public title: Effect of supplementation in treatment of women with cervical intraepithelial neoplasia 2 and 3
• Scientific title: Clinical trial of the effect of folate supplementation compared with the placebo on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3
• Date of first enrolment: 2017-01-22
• Target sample size: 60
• Recruitment status: Other
• URL: http://en.irct.ir/trial/16171
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: 2

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Mojgan Nourian
• Affiliation: Isfahan University of Medical Science/Nutrition Department

• Name: Mojgan Nourian
• Affiliation: Isfahan University of Medical Science

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: women with cervical intraepithelial neoplasia 2 and 3; aged 18 to 55 years old. Exclusion criterion: unwillingness to cooperate.
Exclusion criteria:

Age minimum: 18 years
Age maximum: 55 years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical intraepithelial neoplasia 2 and 3.
Cervix uteri, unspecified

Cervix uteri, unspecified

Intervention(s)

Intervention 1: Intervention group: Folate supplement, 5 mg, daily, for 12 weeks orally. Intervention 2: Control group: Placebo tablet, daily for 12 weeks orally.

Control group: Placebo tablet, daily for 12 weeks orally.

Treatment - Drugs

Intervention group: Folate supplement, 5 mg, daily, for 12 weeks orally.

Primary Outcome(s)

Recurrence. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Colposcopy.

Secondary Outcome(s)

Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.

Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.

Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

Source(s) of Monetary Support

Vice chancellor for research, Isfahan University of Medical Science

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Isfahan University of Medical Sciences