| CTRI Number |
CTRI/2026/03/106796 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cardiac and metabolic effects of calcium and vitamin-D supplementation with conventional treatment in patients of polycystic ovarian syndrome |
|
Scientific Title of Study
|
Cardiometabolic and hormonal profile in patients of polycystic ovarian syndrome supplemented with calcium and vitamin-D to conventional myo-inositol treatment: a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Khitoliya |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College, Meerut |
| Address |
Department of Pharmacology, LLRM Medical College, Meerut
Meerut
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8755937984 |
| Fax |
|
| Email |
anjaliaug9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Khitoliya |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College, Meerut |
| Address |
Department of Pharmacology, LLRM Medical College, Meerut
Meerut
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8755937984 |
| Fax |
|
| Email |
anjaliaug9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pinki Vishwakarma |
| Designation |
Professor |
| Affiliation |
LLRM Medical College, Meerut |
| Address |
Department of Pharmacology, LLRM Medical College, Meerut
Meerut
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9760030221 |
| Fax |
|
| Email |
drpinkivkm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology,
LLRM Medical College, Meerut
Meerut
UTTAR PRADESH
250004 |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology |
| Address |
LLRM Medical College, Meerut UTTAR PRADESH 250004 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Khitoliya |
LLRM Medical College Meerut |
Department of Pharmacology, Third floor, Clinical Pharmacology Lab, LLRM Medical College, Meerut 250004
Meerut
UTTAR PRADESH |
8755937984
anjaliaug9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee LLRM Medical College Meerut |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium 500 mg + Vitamin D3 250 IU tablet |
Calcium 500 mg + Vitamin D3 250 IU tablet administered orally once daily after meals for 12 weeks |
| Comparator Agent |
Conventional treatment |
Inositol by oral route twice a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
-Patients of 18 to 45 years age group.
-Newly diagnosed PCOS patients as per Rotterdam
Criteria.
-Patients willing to give Consent.
|
|
| ExclusionCriteria |
| Details |
-Patient aged less than 18 years or greater than
45 years.
-Participants who have received vitamin
supplementation, insulin sensitizers or any
other hormonal treatment within the last 3months.
-Patients with known adrenal disorders.
-Patients with thyroid dysfunction.
-Patients with a history of long-standing Diabetes
Mellitus.
-Patients with severe debilitating disorders.
-Patient unwilling to provide voluntary informed
consent for participation.
-Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cardiometabolic and hormonal parameters from baseline to 12 weeks of intervention |
Base line (Day 0) and at 12 weeks after intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PCOS is a common endocrine disorder associated with reproductive, hormonal and metabolic abnormalities. Vitamin-D deficiency is common in these patients and along with calcium imbalance, may worsen metabolic and reproductive dysfunction. Insulin resistance is also a common factor in the etiology of PCOS. Conventional therapy for PCOS includes metformin or myoinositol. Myoinositol improves Insulin sensitivity and hormonal balance in PCOS. Therefore, adding calcium & vitamin-D to myoinositol therapy may provide additional benefits in improving cardiometabolic and hormonal profiles in PCOS. |