The effect of vitamin D3 on benign breast tumor

Phase 3

Recruiting

Conditions: Benign breast disease.
Benign neoplasm of breast

Registration Number: IRCT20100209003320N24

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 48

Inclusion Criteria

Histopathological evidence of BBT (fibrocystic, fibroadenoma, etc.)
Age between 19 and 50 years
At least two years since diagnosis
willingness to cooperate and complete the informed consent form
Serum vitamin D deficiency (less than 20 ng/ml)

Exclusion Criteria

Malabsorption disorders (such as Crohn's disease, celiac disease), biliary tract obstruction
Acute or chronic conditions (including various types of cancer, liver, kidney, and acute heart failure), hyperthyroidism, hormonal disorders prior to diagnosis (e.g., polycystic ovary syndrome (PCOS)), type 1 diabetes, hypoglycemia, adrenal gland disorders
Grade 3 obesity
A daily calorie intake of less than 800 or more than 3500 kcal/d
Asthma
Any benign lesions in other organs
Pregnancy
Lactation
Chemotherapy
Radiotherapy
Hormone therapy
Cystectomy surgery
Use of glucocorticoid, anti-seizure, contraceptive, and HRT medications
Consuming more than 2000 mg of cod liver oil
Taking painkillers containing caffeine

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VDR gene expression. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Real time RT-PCR.;Endocrine parameters. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: ELIZA.;Metabolic parameters. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Enzymatic kits.;Adipokines. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: ELIZA.

Secondary Outcome Measures

Name	Time	Method
utritional status. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: A 24-hour dietary recall in three days (one holiday and two working days) and valid food frequency questionnaire.;Physical activity. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Physical activity questionnaire.;Anthropometric status. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Centimeter, Scale.