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Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Lipid Profile in Vitamin D Deficient/Insufficient Polycystic Ovary Syndrome Patients:A Randomized, Placebo-Controlled Clinical Trial


Affiliations
1 Department of Pharmaceutics and Pharmaceutical Technology, Damascus University, Damascus, Syrian Arab Republic
2 Department of Embryology and Reproductive Medicine, Damascus University, Damascus, Syrian Arab Republic
     

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Objective: This study aims to investigate the impact of combining calcium and vitamin D supplements with metformin on lipid profile in vitamin D deficient/insufficient polycystic ovary syndrome (PCOS) women. Study design: A randomized, placebo-controlled clinical trial. Setting: Damascus University of Obstetrics and Gynecology Hospital and Orient Hospital, in Damascus, Syria. Materials and methods: Forty PCOS women with 25-hydroxyvitamin D < 30 ng/mL were randomly assigned to take either metformin (1500 mg/daily) plus placebo or metformin (1500 mg/daily) plus calcium (1000 mg/daily) and vitamin D3 (6000 IU/daily) orally for 8 weeks. Fasting serum levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), triglyceride (TG) and non-HDL cholesterol (non-HDL) were detected at the baseline and after 8 weeks of intervention. Results: Of all participants, thirty-four completed the study. After 8 weeks of intervention, calcium and vitamin D levels increased significantly in the supplementation group, but no significant changes in the lipid profile were noticed in both groups. Conclusions: Adding calcium and vitamin D to metformin therapy had no superior effect on improving lipid profile in vitamin D deficient/insufficient subjects with PCOS. The Clinical Trial Registration Number is NCT03792984.

Keywords

Polycystic Ovary Syndrome, Lipid Profile, Calcium, Vitamin D, Metformin.
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  • Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Lipid Profile in Vitamin D Deficient/Insufficient Polycystic Ovary Syndrome Patients:A Randomized, Placebo-Controlled Clinical Trial

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Authors

Sally Kadoura
Department of Pharmaceutics and Pharmaceutical Technology, Damascus University, Damascus, Syrian Arab Republic
Marwan Alhalabi
Department of Embryology and Reproductive Medicine, Damascus University, Damascus, Syrian Arab Republic
Abdul Hakim Nattouf
Department of Pharmaceutics and Pharmaceutical Technology, Damascus University, Damascus, Syrian Arab Republic

Abstract


Objective: This study aims to investigate the impact of combining calcium and vitamin D supplements with metformin on lipid profile in vitamin D deficient/insufficient polycystic ovary syndrome (PCOS) women. Study design: A randomized, placebo-controlled clinical trial. Setting: Damascus University of Obstetrics and Gynecology Hospital and Orient Hospital, in Damascus, Syria. Materials and methods: Forty PCOS women with 25-hydroxyvitamin D < 30 ng/mL were randomly assigned to take either metformin (1500 mg/daily) plus placebo or metformin (1500 mg/daily) plus calcium (1000 mg/daily) and vitamin D3 (6000 IU/daily) orally for 8 weeks. Fasting serum levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), triglyceride (TG) and non-HDL cholesterol (non-HDL) were detected at the baseline and after 8 weeks of intervention. Results: Of all participants, thirty-four completed the study. After 8 weeks of intervention, calcium and vitamin D levels increased significantly in the supplementation group, but no significant changes in the lipid profile were noticed in both groups. Conclusions: Adding calcium and vitamin D to metformin therapy had no superior effect on improving lipid profile in vitamin D deficient/insufficient subjects with PCOS. The Clinical Trial Registration Number is NCT03792984.

Keywords


Polycystic Ovary Syndrome, Lipid Profile, Calcium, Vitamin D, Metformin.

References