Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Leiomyoma

Myofibroma

Genital Diseases, Female

Vitamin D Deficiency

Genital Diseases

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vitamins

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Patients in this group would take Vitamin D3 400 UNT Oral Capsule.

Patients in this group would take nothing.

50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.

Vitamin D3 400 UNT Oral Capsule

Xueqiong Zhu, PHD

TING LI

The aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids in reproductive stage women.

A total of 1160 hypovitaminosis D patients (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml) without uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group and control group. The intervention group will receive 1600 IU/d of vitamin D3; the control group will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the incidence of uterine fibroids in different groups.

Association Between Vitamin D and the Risk of Uterine Fibroids

Incidence rate of uterine fibroids in different groups after two years treatment

Alanine aminotransferase (ALT) or aspartate transaminase (AST) more than 3 times of the normal upper limit, or total bilirubin (TBIL) more than 2 times of the normal upper limit

Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min

Incidence rate of uterine fibroids in different groups after one year treatment

Second Affiliated Hospital of Wenzhou Medical University

Hydroxycholecalciferols

Calcifediol

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years

patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml)and uterine fibroids receive regular follow-up.

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3

patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 30 ng/ml)and uterine fibroids receive regular follow-up.

Non-Vitamin D3 Drops group Patients in this group would take nothing.

Vitamin D 3

the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.

180 patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml) and uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group A and control group B. 180 patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 30 ng/ml) and uterine fibroids will be also randomly assigned in a ratio of 1:1 to two groups: intervention group C and control group D. The intervention group A will receive 1600 IU/d of vitamin D3; The intervention group C will receive 800 IU/d of vitamin D3; the control group B and the control group D will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the growth of uterine fibroids in different groups.

Association Between Vitamin D and the Development of Uterine Fibroids

percent change in volume of the largest fibroid compared to baseline in different groups

percentage of subjects undergoing other medical or surgical treatment of uterine fibroids

Alanine aminotransferase (ALT) or aspartate transaminase (AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit

Creatinine levels ≧ 1.4 mg/dL (123μmol/L) or creatinine clearance ≦ 50 mL/min

percent change in volume of the total fibroids compared to baseline in different groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Association Between Vitamin D and the Risk of Uterine Fibroids	NCT03586947	Gynaecological ... Vitamin D Defic... Uterine Fibroid...	Vitamin D3 400 ...	35 Years - 50 Years	Second Affiliated Hospital of Wenzhou Medical University
Association Between Vitamin D and the Development of Uterine Fibroids	NCT03584529	Gynaecological ... Vitamin D Defic...	Vitamin D 3	35 Years - 50 Years	Second Affiliated Hospital of Wenzhou Medical University
Association Between Vitamin D and the Development of Uterine Fibroids	NCT03584529	Gynaecological ... Vitamin D Defic...	Vitamin D 3	35 Years - 50 Years	Second Affiliated Hospital of Wenzhou Medical University
Association Between Vitamin D and the Development of Uterine Fibroids	NCT03584529	Gynaecological ... Vitamin D Defic...	Vitamin D 3	35 Years - 50 Years	Second Affiliated Hospital of Wenzhou Medical University

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