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Vitamin D in women with polycystic ovary syndrome

Vitamin D and clomiphene citrate versus clomiphene citrate only for ovulation induction in women with PCOS: A randomized double-blind, placebo-controlled clinical trial

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000780954
Enrollment
20
Registered
2011-07-26
Start date
2011-07-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

All women with PCOS who fullfiled the criteria and agreed to participate in the study will be randomized (by computer-generated randomization) into two groups. Group 1 will be treated with Vitamin D 50000 units orally for the first week followed by 1000 units daily for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate for five days from day three of the menstrual period. Group 2 will be treated with placebo for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate for five days from day three of menses. Ovulation is confirmed by midluteal serum P values of > 8.0 ng / ml.

Interventions

All women with PCOS who fullfiled the criteria and agreed to participate in the study will be randomized (by computer-generated randomization) into two groups. Group 1 will be treated with Vitamin D 50000 units once orally for the first week followed by 1000 units orally daily for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate daily orally for five days from day three of the menstrual period. Group 2 will be treated with plac

All women with PCOS who fullfiled the criteria and agreed to participate in the study will be randomized (by computer-generated randomization) into two groups. Group 1 will be treated with Vitamin D 50000 units once orally for the first week followed by 1000 units orally daily for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate daily orally for five days from day three of the menstrual period. Group 2 will be treated with placebo once orally in the first week followed by placebo daily orally for three months starting from the first day of a spontaneous cycle or progestin withdrawal and 100 mg clomiphene citrate daily orally for five days from day three of menses. Ovulation is confirmed by midluteal serum P values of > 8.0 ng / ml.

Sponsors

King Abdulaziz University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Women attending the infertility clinics at King Abdulaziz University Hospital. PCOS is being defined as any women with two out of three criteria 1). Oligo- or anovulation; 2). Clinical and/or biochemical signs of hyperandrogenism; and 3). Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome)

Exclusion criteria

Refusal to participate in the study Male factor infertility Fallopian tubal disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026