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IRCT20251121068065N6 IRCT 2026-06-16 Shahid Beheshti University of Medical Sciences The effect of vitamin D on the cumulative size and number of uterine fibroids in women aged 30-45 years with uterine fibroids and hypovitaminosis D. The effect of vitamin D on the cumulative size and number of uterine fibroids in women aged 30-45 years with uterine fibroids and hypovitaminosis D. 2026-06-28 anticipated 130 Recruiting https://irct.ir/trial/90753 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to the intervention (vitamin D) or control (placebo) group in a 1:1 ratio using a sealed, opaque envelope randomization method. The randomization sequence will be generated by an independent investigator using Microsoft Excel prior to participant enrollment. Group allocation cards will be prepared in equal numbers and placed in sequentially numbered, opaque, sealed envelopes. After enrollment, each participant will be assigned to a study group by selecting one envelope. This procedure will ensure random allocation and concealment of group assignment throughout the enrollment process, Blinding description: This study will be conducted using a double-blind design. Participants will be unaware of their group allocation (vitamin D or placebo). In addition, the sonographer responsible for ultrasonographic assessments and the experienced midwife involved in participant follow-up and outcome assessment will be blinded to treatment allocation. Therefore, both participants and outcome assessors will remain unaware of group assignment throughout the study. 2 Leiomyoma of uterus (Uterine fibroids). Intervention 1: Control group: Participants will receive a placebo administered according to the same dosing schedule and duration as the intervention group. Intervention 2: Intervention group: Participants with vitamin D insufficiency (12–20 ng/mL) will receive oral vitamin D 1000 IU daily for 3 months. Participants with vitamin D deficiency (<12 ng/mL) will receive vitamin D 50,000 IU weekly for 6–8 weeks followed by 1000 IU daily until completion of the 3-month intervention period. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Noushin Amjadi
Shahid Beheshti University of Medical Sciences, Faculty of Medicine, Kokod Yar Street, Daneshjoo Blvd., Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 912 616 9342 nooshinamjadi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr. Maryam Talayeh
Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Near Ayatollah Taleghani Hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 7755 3112 m_talayeh@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women aged 30–45 years who are premenopausal. Presence of uterine fibroids confirmed by abdominal and transvaginal ultrasonography. Total fibroid volume between 64 and 512 cm³. Serum 25-hydroxyvitamin D [25(OH)D] level <20 ng/mL (vitamin D deficiency or insufficiency). Provision of written informed consent. 30 years 45 years Female Malabsorption disorders. Chronic kidney disease or renal failure. Severe fibroid-related symptoms requiring immediate treatment (e.g., heavy bleeding causing anemia, severe pelvic pain, or significant urinary tract compression). Cardiovascular disease. Diabetes mellitus. Any malignancy. Osteomalacia or osteoporosis requiring therapeutic vitamin D supplementation. Withdrawal of consent or unwillingness to continue participation. D25 Leiomyoma of uterus Treatment - Drugs Treatment - Drugs Control group: Participants will receive a placebo administered according to the same dosing schedule and duration as the intervention group. Intervention group: Participants with vitamin D insufficiency (12–20 ng/mL) will receive oral vitamin D 1000 IU daily for 3 months. Participants with vitamin D deficiency (<12 ng/mL) will receive vitamin D 50,000 IU weekly for 6–8 weeks followed by 1000 IU daily until completion of the 3-month intervention period. Number and cumulative size of uterine fibroids. Timepoint: The number and cumulative volume of uterine fibroids will be assessed at two time points: baseline (prior to initiation of the intervention) and at the end of the 3-month intervention period (post-intervention). Method of measurement: Fibroid number and cumulative volume will be assessed by transabdominal ultrasonography (TAS) and transvaginal ultrasonography (TVS) performed by a trained sonographer. Serum 25-hydroxyvitamin D [25(OH)D] level. Timepoint: Serum 25-hydroxyvitamin D levels will be measured at two time points: baseline (before initiation of the intervention) and upon completion of the 3-month intervention period. Method of measurement: Serum 25-hydroxyvitamin D [25(OH)D] levels will be measured using high-performance liquid chromatography (HPLC) with a Pars Azmoon Chromium assay kit. Shahid Beheshti University of Medical Sciences Approved 2026-05-19 Research Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences 6th Floor, Building No. 2, Shahid Beheshti University of Medical Sciences Headquarters, Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)