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Clinical Trials/CTRI/2018/04/013220
CTRI/2018/04/013220
Recruiting
未知

A Clinical Study to Determine Association of Serum Vitamin D and Serum Prolactin with Uterine Fibroid in Indian Population

Asheesh Sachdeva0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Uterine Fibroid Female otherwise healthy
Sponsor
Asheesh Sachdeva
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Asheesh Sachdeva

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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