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Vitamin D3 and Prolactin measurement in female subjects having fibroids in uterus

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/04/013220
Enrollment
154
Registered
2018-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Uterine Fibroid Female otherwise healthy

Interventions

None listed

Sponsors

Asheesh Sachdeva
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
1.To determine association of serum Prolactin with uterine fibroid. 2.To determine association of serum Vitamin D3 with uterine fibroid. Timepoint: After completion of subject enrollment

Secondary

MeasureTime frame
1.To determine association of serum Prolactin with number, size & location of uterine fibroids. 2.To determine association of serum Vitamin D3 with number, size & location of uterine fibroids Timepoint: After completion of subject enrollment

Countries

India

Contacts

Public ContactASHEESH SACHDEVA

Artemis Hospital

anjalik@artemishospitals.com9810121755

Outcome results

None listed

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