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The effect of vitamin D3 on benign breast tumor

The effect of vitamin D3 supplementation (cholecalciferol) on nutritional status, VDR gene expression, endocrine, metabolic, and adipokine parameters in patients with benign breast tumors:Randomized controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100209003320N24
Enrollment
48
Registered
2024-07-18
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign breast disease. Benign neoplasm of breast

Interventions

Intervention 1: Intervention group:Consume one pearl of vitamin D3 50,000 IU per week for 8 weeks. Participants will be advised to maintain their usual lifestyle, including their habitual diet.All par

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
19 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Nutritional 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mehrangiz Ebrahimi- Mameghani

Tabriz University of Medical Sciences

ebrahimimamagani@tbzmed.ac.ir+98 41 3335 7584

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026