The effect of vitamin D supplementation in combination with low-calorie diet on anthropometric indices and androgen hormones in women with polycystic ovary syndrome: a double-blind, randomized, placebo-controlled trial

J Endocrinol Invest. 2018 May;41(5):597-607. doi: 10.1007/s40618-017-0785-9. Epub 2017 Nov 6.


Purpose: Polycystic ovary syndrome (PCOS) is known as the most common endocrine disorder in reproductive age women. The aim of this studywas to evaluate the effects of vitamin D supplementation in combination with low-calorie diet on anthropometric indices, reproductive hormones and menstrual regularity in overweight and obese PCOS women.

Methods: In this randomized controlled clinical trial, 60 PCOS women with vitamin D insufficiency were randomly assigned to 12 weeks of either (1) weight-loss intervention + 50,000 IU/week oral vitamin D3 or (2) weight-loss intervention + placebo. At the beginning and end of the study, the anthropometric indices, body composition, 25-hydroxyvitamin D, total testosterone, dehydroepiandrosterone sulfate (DHEAS), sex hormone-binding globulin (SHBG) and free androgen index (FAI) were measured and regularity of menses was compared among the two groups.

Result: After 12-week intervention, median of serum 25-hydroxyvitamin D3 significantly increased from 18.5 (10.75-20) ng/ml to 42.69 (34-53.25) ng/ml in vitamin D group compared to placebo group (p < 001). Moreover, there was a significant improvement in frequency regular menstrual cycle (p = 0.01). Mean of weight, body mass index, fat mass, waist and hip circumference and waist-to-hip ratio significantly decreased in both groups, but was not different between two groups. Mean of total testosterone insignificantly decreased from 0.7 to 0.5 ng/ml in vitamin D group (p = 0.18). In addition, we did not observe significant differences regarding DHEAS, FAI and SHBG between two groups.

Conclusions: In women with PCOS, androgen profile did not change with vitamin D supplementation when combined with low-calorie diet, but menstrual frequency significantly improved.

Clinical trial registration number: IRCT2016062710826N19.

Keywords: Androgens; Low-calorie diet; Menstrual cycle; Polycystic ovary syndrome; Randomized controlled trial; Vitamin D.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Androgens / blood*
  • Anthropometry*
  • Biomarkers / analysis
  • Caloric Restriction*
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Insulin Resistance
  • Obesity / blood
  • Obesity / pathology
  • Obesity / therapy
  • Polycystic Ovary Syndrome / blood*
  • Polycystic Ovary Syndrome / pathology
  • Polycystic Ovary Syndrome / therapy*
  • Prognosis
  • Prospective Studies
  • Vitamin D / administration & dosage*
  • Vitamins / administration & dosage


  • Androgens
  • Biomarkers
  • Vitamins
  • Vitamin D