Vitamin-D, Vitamin-B12, Folic acid(Essential vitamins involved in body metabolism) and Beta-hCG(a hormone which is related to pregnancy) levels in benign(not dangerous) and malignant(cancerous) breast disease

Completed

• Conditions: Benign neoplasm of unspecified breast, (2) ICD-10 Condition: E538||Deficiency of other specified B group vitamins, (3) ICD-10 Condition: C50||Malignant neoplasm of breast, (4) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,

• Registration Number: CTRI/2021/01/030418
• Lead Sponsor: Uttar Pradesh University of Medical Sciences

Brief Summary

This is a prospective, cross-sectional, observational study aimed at finding the association of benign and malignant breast diseases with deranged circulating serum levels of the important bodily vitamins such as Vitamin-D, Vitamin-B12, Folic acid and also to correlate with the circulating serum levels of Beta-hCG. The primary objective is to draw a correlation between the dietary and nutritional factors involved in the pathogenesis or causation of benign and malignant breast diseases in Indian women.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study Completion: 2021-09-25
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Female patients with Benign and malignant breast diseases diagnosed by histopathological examination.

Exclusion Criteria

• Females with pre existing comorbidities.
• Patients on Vitamin-D, Vitamin-B12 and/or Folic acid supplements.
• Patients who are undergoing or had previously undergone cancer chemotherapy.
• Patients with history of gastrointestinal surgery.
• Patients not giving consent to be part of the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
THE PRIMARY OBJECTIVE IS TO FIND THE ASSOCIATION OF BENIGN AND MALIGNANT BREAST DISEASES WITH DERANGED CIRCULATING SERUM LEVELS OF VITAMIN-D, VITAMIN-B12, FOLIC ACID AND BETA-hCG.	AT BASELINE

Secondary Outcome Measures

Name	Time	Method
TO DRAW AN ASSOCIATION BETWEEN DIETARY AND NUTRITIONAL DEFICIENCIES IN THE PATHOGENESIS OR CAUSATION OF BENIGN AND MALIGNANT BREAST DISEASES IN INDIAN WOMEN.	AT BASELINE

Trial Locations

Locations (1)

Uttar Pradesh University of Medical Sciences; 🇮🇳 Etawah, UTTAR PRADESH, India

Uttar Pradesh University of Medical Sciences

🇮🇳Etawah, UTTAR PRADESH, India

Ranjith Kumaran R

Principal investigator

09487555545

ranjithkumaran2009@gmail.com