Vitamin D3 and Prolactin measurement in female subjects having fibroids in uterus
- Conditions
- Health Condition 1: null- Uterine Fibroid Female otherwise healthy
- Registration Number
- CTRI/2018/04/013220
- Lead Sponsor
- Asheesh Sachdeva
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria for cases
1.Female subjects with 18 to 50 years of age (both inclusive) who are in perimenopausal status.
2.Documented evidence of atleast one uterine fibroid lesion of 2 cm3 or greater on ultrasonography.
3.Ability to provide consent.
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.Ability to provide consent.
1.Pregnant and lactating women
2.Women with a history of abortion or miscarriage in last 6 months
3.Women with 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 last 3 months
5.Women with concomitant use of hormonal treatment (including oral contraceptives) or history of hormonal treatment within 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 1.To determine association of serum Prolactin with uterine fibroid. <br/ ><br>2.To determine association of serum Vitamin D3 with uterine fibroid. <br/ ><br>Timepoint: After completion of subject enrollment
- Secondary Outcome Measures
Name Time Method 1.To determine association of serum Prolactin with number, size & location of uterine fibroids. <br/ ><br>2.To determine association of serum Vitamin D3 with number, size & location of uterine fibroids <br/ ><br>Timepoint: After completion of subject enrollment