Treatment Adherence Clinical Trial
Official title:
Impact of Vitamin D Supplementation on the Cardiometabolic Status and Androgen Profile in Women With Polycystic Ovary Syndrome: Placebo-Controlled Clinical Trial
Verified date | October 2019 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Polycystic ovary syndrome (PCOS) is a heterogeneous disorder of reproductive, endocrine and metabolic functions. Vitamin D has an influence on metabolic and reproductive functions. This study was designed to explore the levels of free 25 hydroxy cholecalciferol [25(OH) D] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation on cardiometabolic status, androgen profile and clinical features of PCOS.
Status | Completed |
Enrollment | 145 |
Est. completion date | July 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 33 Years |
Eligibility |
Inclusion Criteria: 1. women with PCO. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria 2. women must be able to swallow tablets Exclusion Criteria: 1. a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia) 2. DM3-hypertension 3. liver diseases 4. kidney diseases 5. Insulin-dependent diabetes 6. thyroid diseases. 7. women received non-steroidal anti-inflammatory drugs , multivitamins, and hormone replacement therapy. |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig University | Zagazig | El-Shakia |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Bianchini E, Bozec E, Gemignani V, Faita F, Giannarelli C, Ghiadoni L, Demi M, Boutouyrie P, Laurent S. Assessment of carotid stiffness and intima-media thickness from ultrasound data: comparison between two methods. J Ultrasound Med. 2010 Aug;29(8):1169-75. — View Citation
Bikle D. Nonclassic actions of vitamin D. J Clin Endocrinol Metab. 2009 Jan;94(1):26-34. doi: 10.1210/jc.2008-1454. Epub 2008 Oct 14. Review. — View Citation
Dunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. Review. — View Citation
FERRIMAN D, GALLWEY JD. Clinical assessment of body hair growth in women. J Clin Endocrinol Metab. 1961 Nov;21:1440-7. — View Citation
Franks S. Polycystic ovary syndrome. N Engl J Med. 1995 Sep 28;333(13):853-61. Review. Erratum in: N Engl J Med 1995 Nov 23;333(21):1435. — View Citation
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. — View Citation
Hahn S, Haselhorst U, Tan S, Quadbeck B, Schmidt M, Roesler S, Kimmig R, Mann K, Janssen OE. Low serum 25-hydroxyvitamin D concentrations are associated with insulin resistance and obesity in women with polycystic ovary syndrome. Exp Clin Endocrinol Diabetes. 2006 Nov;114(10):577-83. — View Citation
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation
Kakarala RR, Chandana SR, Harris SS, Kocharla LP, Dvorin E. Prevalence of vitamin D deficiency in uninsured women. J Gen Intern Med. 2007 Aug;22(8):1180-3. Epub 2007 Jun 2. — View Citation
Lorenz LB, Wild RA. Polycystic ovarian syndrome: an evidence-based approach to evaluation and management of diabetes and cardiovascular risks for today's clinician. Clin Obstet Gynecol. 2007 Mar;50(1):226-43. Review. — View Citation
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. — View Citation
Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. — View Citation
Schmidt-Trucksäss A, Grathwohl D, Schmid A, Boragk R, Upmeier C, Keul J, Huonker M. Structural, functional, and hemodynamic changes of the common carotid artery with age in male subjects. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):1091-7. — View Citation
Stein JH, Korcarz CE, Hurst RT, Lonn E, Kendall CB, Mohler ER, Najjar SS, Rembold CM, Post WS; American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Use of carotid ultrasound to identify subclinical vascular disease and evaluate cardiovascular disease risk: a consensus statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine. J Am Soc Echocardiogr. 2008 Feb;21(2):93-111; quiz 189-90. doi: 10.1016/j.echo.2007.11.011. Review. Erratum in: J Am Soc Echocardiogr. 2008 Apr;21(4):376. — View Citation
Talbott E, Guzick D, Clerici A, Berga S, Detre K, Weimer K, Kuller L. Coronary heart disease risk factors in women with polycystic ovary syndrome. Arterioscler Thromb Vasc Biol. 1995 Jul;15(7):821-6. — View Citation
Victor VM, Rocha M, Bañuls C, Alvarez A, de Pablo C, Sanchez-Serrano M, Gomez M, Hernandez-Mijares A. Induction of oxidative stress and human leukocyte/endothelial cell interactions in polycystic ovary syndrome patients with insulin resistance. J Clin Endocrinol Metab. 2011 Oct;96(10):3115-22. doi: 10.1210/jc.2011-0651. Epub 2011 Jul 21. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of lipid profiles in intervention arm of PCOS patients who received vitamin d supplementation | change of LDL (mg/dl), TG (mg/dl) TG (mg/dl) ,(mg/dl) | 12 weeks | |
Primary | Improvement of fertility ;ovarian size | Ovarian volume cm were evaluated by transvaginal ultrasound | 12 weeks | |
Primary | change of vitamin D deficiency | Serum concentrations of 25(OH)-D( ng/ml ) | 12 weeks | |
Primary | Change of androgenic levels in intervention arm of PCOS patients who received vitamin d | total testosterone (ng/mL), | 12 weeks | |
Primary | Change of inflammatory markers in intervention arm of PCOS patients who received vitamin d | hs-CRP (µg/ml) | 12 weeks | |
Primary | change of BMI | weight in kilograms, height in meters | 12 weeks | |
Primary | change of fertility , antral follicular count | antral follicular count were evaluated by transvaginal ultrasound | 12 weeks |
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