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Effect of calcitriol in PCOS

Comparison of calcitriol and metformin treatment on improvement of clinical and metabolic complications of polycystic ovary syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108074167N4
Enrollment
51
Registered
2012-01-21
Start date
2011-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Metformin, 500 mg/ bid for three months. Intervention 2: Calcitriol, 0.25 microgram bid for three months. Intervention 3: Placebo, two tablet in day for three months.
Treatment - Drugs
Placebo
Metformin, 500 mg/ bid for three months
Calcitriol, 0.25 microgram bid for three months
Placebo, two tablet in day for three months

Sponsors

Vice chancelor for research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 40 Years

Inclusion criteria

Inclusion criteria: Presence of two criteria of these three was necessary: 1 – Anovulation or oligoovulation (or menstrual cycle less than 6 cycles in 12 month) 2 – Clinical or biochemical symptoms of hyperandrogenemia include: acne, hirsutism , alopecia or increased serum androgen levels . 3- View of polycystic ovary with 12 follicles or more in each ovary with diameter between 2-9 mm or increased ovarian volume more than 10 cm3 by ultrasound. For other cause of hyperandrogenism including : congenital adrenal hyperplasia , Cushing's syndrome , hyperprolactinemia, hypothyroidism and tumors that secrete androgens were excluded by laboratory markers.With regard to the check of the 25 hydroxy vitamin D level in patients , we excluded all the patients that had systemic factors that interfere on vitamin D level like : history of renal disease , hepatic disease , malabsorption, alcoholism , breastfeeding , pregnancy and all the people who used drugs that effective on vitamin D level like : anti epileptic agents , supplement of calcium and vitamins and glucocorticoids

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Insulin resistance. Timepoint: 3 months. Method of measurement: Lab data , FBS and insulin level.

Secondary

MeasureTime frame
Ovulation. Timepoint: 3 months. Method of measurement: Sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShokoufeh Bonakdaran

Fellowship of endocrinology

bonakdaransh@mums.ac.ir+98 51 1801 2976

Outcome results

None listed

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