Study on uterine fibroid with vitamin D and prolactin.
- Conditions
- Health Condition 1: - Health Condition 2: O262- Pregnancy care for patient with recurrent pregnancy loss
- Registration Number
- CTRI/2022/09/045404
- Lead Sponsor
- ot Applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion criteria for case:
1.Female subjects with 18 to 50 years of age (both inclusive) who are in pre-menopausal status.
2.Documented evidence of atleast one uterine fibroid lesion of 2 cm3 or greater on ultrasonography.
3.Willing to participate in the study.
Inclusion criteria for control:
1.Female subjects with 18 to 50 years of age (both inclusive) who are in pre-menopausal status.
2.Documented evidence of no uterine fibroid lesion on ultrasonography.
3.Willing to participate in the study.
Exclusion criteria for both cases and controls:
1.Pregnant and lactating women.
2.Women with a history of abortion or miscarriage in the last 6 months.
3.Women with a history of prior surgery for fibroids (myomectomy) or hysterectomy.
4.Women with concomitant use of vitamin D supplements or history of vitamin D supplement within the last 3 months.
5.Women with concomitant use of hormonal treatment (including oral contraceptives) or history of hormonal treatment within the last 3 months.
6.Women with concomitant use of drug known to increase the serum prolactin levels [e.g., haloperidol, chlorpromazine, thioridazine, thiothixene (typical antipsychotics); risperidone, amisulpride, molindone, zotepine (atypical antipsychotics); sertraline, fluoxetine, paroxetine, pargyline, clorgyline (antidepressants); buspirone, alprazolam (psychotropics); metoclopramide and domperidone (prokinetics), alpha-methyldopa, reserpine and verapamil (antihypertensive), morphine (opiates)].
7.Women with diabetes mellitus, pituitary, and hypothyroidism, chronic renal failure, or psychiatric disease
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The association of serum levels of Vitamin D3 and Prolactin will be evaluated in Patients with uterine fibroids and it will compare with healthy individuals.Timepoint: 12 Weeks
- Secondary Outcome Measures
Name Time Method The association of serum levels of Vitamin D3 and Prolactin will be evaluated with number and size of uterine fibroids.Timepoint: 20 Weeks