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The effects of vitamin D2 supplementation on serum high sensitivity C-reactive protein and metabolic profiles in overweight or obese women with PCOS: a randomized, double-blind, placebo-controlled trial

The effects of vitamin D2 supplementation on serum high sensitivity C-reactive protein and metabolic profiles in overweight or obese women with PCOS: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221206004
Enrollment
78
Registered
2022-12-06
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Overweight or obese women with polycystic ovary syndrome with hypovitaminosis D PCOS, polycystic ovary syndrome, vitamin D2, ergocalciferol, inflammatory markers

Interventions

Vitamin D2 (calciferol) 20,000 IU per capsule, given to participant 1 capsule twice a week for 12 weeks,Placebo capsules are identical to the vitamin D2, given to participant 1 capsule twice a week fo
Experimental Drug,Placebo Comparator No treatment
Vitamin D group,Placebo group

Sponsors

Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of PCOS based on the Rotterdam criteria (two of the followings : oligo- and/or anovulation, hyperandrogenism and polycystic ovaries) 2. Overweight or obese women: BMI > 23 kg/m2 3. Serum 25-OH vitamin D < 30 ng/ml

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women 2. Smoking 3. Diabetes 4. Thyroid dysfunction 5. Hyperprolactinemia 6. Hypertension 7. Cardiovascular or cerebrovascular disease 8. Chronic kidney disease 9. Chronic liver disease 10. Taking any form of vitamin D or calcium supplement within the last 3 months 11. Known hypersensitivity to vitamin D 12. Taking insulin sensitizer eg. Metformin, insulin, antihypertensives, statins of fibrates within the last 3 months 13. Serum calcium > 10.1 mg/dl 14. History of illnesses from infection or trauma that require hospital visit or admission

Design outcomes

Primary

MeasureTime frame
hsCRP 12 weeks Serum sample on a COBASVR INTEGRA system (Roche Diagnostics, Basel, Switzerland) by particle-enhanced immunoturbidimetry assay (mg/L)—

Secondary

MeasureTime frame
Serum 25-OH vitamin D, fasting plasma glucose, lipid profile, serum calcium 12 weeks Venous blood sample. Biochemical assays will be performed in the Department of Clinical Pathology, Sirriaj Hospital (ISO 15189 certified laboratory).—

Countries

Thailand

Contacts

Public ContactMatus Phunyammalee

Faculty of Medicine Siriraj Hospital, Mahidol University

mphunyammalee@gmail.com0840152912

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026