Polycystic Ovary SyndromePhase 3NCT03792984

The Effect of Calcium and Vitamin D Supplements on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients

A Phase 3 study testing Vitamin D3, Calcium Carbonate and Metformin in people with Polycystic Ovary Syndrome and Vitamin D Deficiency/Insufficiency, run by Damascus University at 2 sites in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to investigate the safety and metabolic-hormonal efficiency of supplementation vitamin D deficient/insufficient PCOS women with (calcium +vitamin D + metformin) for 8 weeks compared to (placebo+ metformin). Read more about this study

Who is it for?: Ages 18 to 30 years, women only
Conditions the study is for: Polycystic Ovary Syndrome, Vitamin D Deficiency/Insufficiency
What is being tested?: Vitamin D3, Calcium Carbonate and Metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 2 sitesSyria
Study dates: 1 Dec 2016to 30 Dec 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Women only
No healthy volunteers
Adult

Who may be able to join

PCOS women aged 18-30 years diagnosed according to the Rotterdam criteria.
Vitamin D deficiency or insufficiency according to the Endocrine Society Clinical Practice Guideline.
Normal liver function.
Normal kidney function.

Who cannot join

Pregnant, postpartum or breastfeeding women.
Females aged <18 or >30 years old.
Patients who were diagnosed with androgen-secreting tumours, Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia, hypercalcemia, malabsorption disorders, diabetes mellitus, thyroid disorders, liver disease, renal disease, epilepsy, cardiovascular disease.
History of kidney stones.
Usage of any hormonal therapy, corticosteroids (other than topical corticosteroids forms), insulin sensitizers, hypolipidemic agents, anti-obesity medications, vitamin D or calcium supplements, anti-epileptic drugs, or any other drugs known to affect endocrine parameters, carbohydrate metabolism, or calciotropic hormone concentrations during the last 3 months.

Trial locations and contacts

2 sites in 1 country.

Syria2 sites

Damascus University of Obstetrics and Gynecology Hospital
Damascus
Orient Hospital
Damascus

Other trials in Syria

About this study

Official title: The Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients

Read the detailed description

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among females of reproductive age. The main manifestations of this syndrome are ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. Noticeably, PCOS is associated with several metabolic disturbances such as insulin resistance, compensatory hyperinsulinemia, dyslipidemia and central obesity, which increase the risk for long-term complications like type 2 diabetes mellitus, metabolic syndrome, and cardiovascular diseases. Moreover, previous data demonstrated that, compared to normo-ovulatory women, PCOS patients might exhibit a dysregulation in the IGF system represented as an elevation in the serum levels of free Insulin-like growth factor-1 (IGF-1) and a reduction in the serum levels of Insulin-like growth factor binding protein-1 (IGFBP-1). However, the exact aetiology of PCOS remains unclear and current treatments are only moderately effective at controlling PCOS symptoms and preventing its complications. Growing evidence suggests a role of vitamin D in female reproductive diseases as the expression of Vitamin D Receptors (VDR) was identified in many organs throughout the female reproductive tract. On the top of that, vitamin D regulates over 300 genes, including genes that are important for glucose and lipid metabolism. Moreover, vitamin D deficiency is a common condition among women with PCOS, and several studies indicated an association between low levels of serum 25-hydroxyvitamin D (25-OH-Vitamin D) and manifestations of PCOS including insulin resistance, hyperandrogenism, and infertility. Further, a recent in-vitro study showed that vitamin D regulated steroidogenesis and IGFBP-1 production in cultured human ovarian cells, and many reports have suggested an interrelation between IGF-1 and vitamin D.

Conditions: Polycystic Ovary Syndrome, Vitamin D Deficiency/Insufficiency
Being tested: Vitamin D3, Calcium Carbonate, Metformin, Placebo
Keywords: Polycystic Ovary Syndrome, Calcium, Vitamin D, Metformin
Medical subject headings: Polycystic Ovary Syndrome, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Dietary supplement
Vitamin D3 (Cholecalciferol) (6000 IU/daily). PO for 8 weeks.
Calcium CarbonateDietary supplement
Calcium carbonate (1000 mg/daily). PO for 8 weeks.
MetforminDrug
Metformin (1500 mg/daily; the metformin dose was increased stepwise, starting with 500 mg once daily for the 1st week, 500 mg twice daily in the 2nd week, followed by 500 mg 3 times daily from the 3rd week onward). PO for 8 weeks.
PlaceboDrug
PO for 8 weeks.

Study groups in NCT03792984
Study group	Role	What they receive
Metformin + Placebo	Placebo comparator	Not described Receives: Drug: Metformin; Drug: Placebo
Calcium carbonate + Vitamin D3 + Metformin	Experimental	Not described Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium Carbonate; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in quantitative insulin sensitivity check index (QUICKI).
Assessment of QUICKI index at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks weeks.
Change in Raynaud's index.
Assessment of Raynaud's index at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks weeks.
Change in McAuley Index.
Assessment of McAuley Index at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks weeks.

Secondary outcomes (25)

Change in glucose concentration.
Assessment of serum concentration of glucose at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in insulin concentration.
Assessment of serum concentration of insulin at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in homeostasis model assessment of insulin resistance index (HOMA-IR).
Assessment of HOMA-IR index at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in homeostasis model assessment of β-cell function index (HOMA-B).
Assessment of HOMA-B index at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in menstrual cycle abnormalities.
Assessment of menstrual cycles regularity (having normal menstrual cycle 21-35 days) was done at baseline and during the study period using a calendar by recording the time of the onset of the menstrual periods and the duration of menses.
Measured: up to 8 weeks.
Change in hirsutism score
Assessment of modified Ferriman-Gallwey score for hirsutism at baseline and after 8 weeks of intervention. (The score represents the hair growth in a male pattern on a woman shown in four different degrees of severity ( 0= no hair growth; 1= light hair growth; 2= moderate hair growth; 4= severe hair growth) in 9 different body parts; namely the upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, upper arms and thighs. The score is the sum of each region sub-score. Thus, it ranges between 0 and 36, where a score ≥ 6 was considered as a cut off Hirsutism).
Measured: baseline, 8 weeks.
Change in free testosterone concentration
Assessment of serum free testosterone concentration at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in serum concentration of follicle-stimulating hormone (FSH)
Assessment of serum concentration of FSH during the early follicular phase of menses at baseline and after 8 weeks of intervention if menstrual cycle regularity was reached during treatment period, or at baseline and the next spontaneous menstrual cycle after finishing the treatment if menstrual cycle regularity was not reached during treatment period.
Measured: baseline, 8 weeks or the next spontaneous menstrual cycle depending on menstrual cycle status.
Change in serum concentration of luteinizing hormone (LH) .
Assessment of serum concentration of LH during the early follicular phase of menses at baseline and after 8 weeks of intervention if menstrual cycle regularity was reached during treatment period, or at baseline and the next spontaneous menstrual cycle after finishing the treatment if menstrual cycle regularity was not reached during treatment period.
Measured: baseline, 8 weeks or the next spontaneous menstrual cycle depending on menstrual cycle status.
Change in serum concentration of Insulin-like growth factor-1 (IGF-1).
Assessment of serum concentration of IGF-1 at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in serum concentration of Insulin-like growth factor binding protein-1 (IGFBP-1).
Assessment of serum concentration of IGFBP-1 at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in IGF-1 to IGFBP-1 ratio.
Assessment of serum concentration of IGF-1 to IGFBP-1 ratio at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in lipid profile.
Assessment of serum concentration of total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), triglyceride (TG) and non-HDL cholesterol (non-HDL) at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in serum concentration of C-reactive protein (CRP)
Assessment of serum concentration of CRP at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in Body mass index (BMI).
Assessment of weight and height in an overnight fasting status without shoes with light clothes at baseline and after 8 weeks of intervention. Weight and height will be combined to report BMI in kg/m^2.
Measured: baseline, 8 weeks.
Change in waist circumference.
Assessment of waist circumference in an overnight fasting status without shoes with light clothes at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in Hip circumference.
Assessment of Hip circumference in an overnight fasting status without shoes with light clothes at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in waist to hip ratio.
Assessment of waist to hip ratio in an overnight fasting status without shoes with light clothes at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in calcium concentration.
Assessment of serum concentration of calcium at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in 25-OH-vitamin D concentration.
Assessment of serum concentration of 25-OH-vitamin D at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in phosphorus concentration.
Assessment of serum concentration of phosphorus at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in alanine transaminase (ALT) concentration.
Assessment of serum concentration of ALT at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in aspartate transaminase (AST) concentration.
Assessment of serum concentration of AST at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in urea concentration.
Assessment of serum concentration of urea at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.
Change in creatinine concentration.
Assessment of serum concentration of creatinine at baseline and after 8 weeks of intervention.
Measured: baseline, 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201630 Dec 2017

First posted4 Jan 2019
Study start1 Dec 2016
Primary completion1 Oct 2017
Study completion30 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03792984
Sponsor's protocol ID: Ph-CT-2685
Status last verified: Dec 2018
First submitted: 18 Dec 2018
Last updated: 6 Jun 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Ameri P, Giusti A, Boschetti M, Murialdo G, Minuto F, Ferone D. Interactions between vitamin D and IGF-I: from physiology to clinical practice. Clin Endocrinol (Oxf). 2013 Oct;79(4):457-63. doi: 10.1111/cen.12268. Epub 2013 Aug 9.
PubMed 23789983
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. doi: 10.1055/s-2006-948308.
PubMed 17177140
Irani M, Merhi Z. Role of vitamin D in ovarian physiology and its implication in reproduction: a systematic review. Fertil Steril. 2014 Aug;102(2):460-468.e3. doi: 10.1016/j.fertnstert.2014.04.046. Epub 2014 Jun 3.
PubMed 24933120
Krul-Poel YH, Snackey C, Louwers Y, Lips P, Lambalk CB, Laven JS, Simsek S. The role of vitamin D in metabolic disturbances in polycystic ovary syndrome: a systematic review. Eur J Endocrinol. 2013 Oct 23;169(6):853-65. doi: 10.1530/EJE-13-0617. Print 2013 Dec.
PubMed 24044903
Li HW, Brereton RE, Anderson RA, Wallace AM, Ho CK. Vitamin D deficiency is common and associated with metabolic risk factors in patients with polycystic ovary syndrome. Metabolism. 2011 Oct;60(10):1475-81. doi: 10.1016/j.metabol.2011.03.002. Epub 2011 May 6.
PubMed 21550088
Ott J, Wattar L, Kurz C, Seemann R, Huber JC, Mayerhofer K, Vytiska-Binstorfer E. Parameters for calcium metabolism in women with polycystic ovary syndrome who undergo clomiphene citrate stimulation: a prospective cohort study. Eur J Endocrinol. 2012 May;166(5):897-902. doi: 10.1530/EJE-11-1070. Epub 2012 Feb 13.
PubMed 22330149
Pal L, Zhang H, Williams J, Santoro NF, Diamond MP, Schlaff WD, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers E, Legro RS; Reproductive Medicine Network. Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Clin Endocrinol Metab. 2016 Aug;101(8):3027-35. doi: 10.1210/jc.2015-4352. Epub 2016 May 17.
PubMed 27186859
Parikh G, Varadinova M, Suwandhi P, Araki T, Rosenwaks Z, Poretsky L, Seto-Young D. Vitamin D regulates steroidogenesis and insulin-like growth factor binding protein-1 (IGFBP-1) production in human ovarian cells. Horm Metab Res. 2010 Sep;42(10):754-7. doi: 10.1055/s-0030-1262837. Epub 2010 Aug 13.
PubMed 20711952
Thierry van Dessel HJ, Lee PD, Faessen G, Fauser BC, Giudice LC. Elevated serum levels of free insulin-like growth factor I in polycystic ovary syndrome. J Clin Endocrinol Metab. 1999 Sep;84(9):3030-5. doi: 10.1210/jcem.84.9.5941.
PubMed 10487660
Kadoura S, Alhalabi M, Nattouf AH. Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Menstrual Cycle Abnormalities, Hormonal Profile, and IGF-1 System in Polycystic Ovary Syndrome Patients: A Randomized, Placebo-Controlled Clinical Trial. Adv Pharmacol Sci. 2019 Jul 1;2019:9680390. doi: 10.1155/2019/9680390. eCollection 2019.
PubMed 31354810

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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Polycystic Ovary Syndrome (PCOS)

All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients
ClinicalTrials.gov ID: NCT03792984
Acronym / sponsor ID: Ph-CT-2685
Conditions: Polycystic Ovary Syndrome, Vitamin D Deficiency/Insufficiency
Keywords: Polycystic Ovary Syndrome, Calcium, Vitamin D, Metformin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 1 Dec 2016 (actual)
Primary completion: 1 Oct 2017 (actual)
Study completion: 30 Dec 2017 (actual)
First posted: 4 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Metformin + Placebo	Placebo comparator	Drug: Metformin, Drug: Placebo
Calcium carbonate + Vitamin D3 + Metformin	Experimental	Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium Carbonate, Drug: Metformin

Who may qualify

Ages: 18 to 30 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

PCOS women aged 18-30 years diagnosed according to the Rotterdam criteria.
Vitamin D deficiency or insufficiency according to the Endocrine Society Clinical Practice Guideline.
Normal liver function.
Normal kidney function.

Key exclusion criteria (5 listed)

Pregnant, postpartum or breastfeeding women.
Females aged <18 or >30 years old.
Patients who were diagnosed with androgen-secreting tumours, Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia, hypercalcemia, malabsorption disorders, diabetes mellitus, thyroid disorders, liver disease, renal disease, epilepsy, cardiovascular disease.
History of kidney stones.
Usage of any hormonal therapy, corticosteroids (other than topical corticosteroids forms), insulin sensitizers, hypolipidemic agents, anti-obesity medications, vitamin D or calcium supplements, anti-epileptic drugs, or any other drugs known to affect endocrine parameters, carbohydrate metabolism, or calciotropic hormone concentrations during the last 3 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3Vitamin D3 (Cholecalciferol) (6000 IU/daily). PO for 8 weeks.	Dietary supplement	Calcium carbonate + Vitamin D3 + Metformin
Calcium CarbonateCalcium carbonate (1000 mg/daily). PO for 8 weeks.	Dietary supplement	Calcium carbonate + Vitamin D3 + Metformin
MetforminMetformin (1500 mg/daily; the metformin dose was increased stepwise, starting with 500 mg once daily for the 1st week, 500 mg twice daily in the 2nd week, followed by 500 mg 3 times daily from the 3rd week onward). PO for 8 weeks.	Drug	Calcium carbonate + Vitamin D3 + Metformin, Metformin + Placebo
PlaceboPO for 8 weeks.	Drug	Metformin + Placebo

Primary outcome

Change in quantitative insulin sensitivity check index (QUICKI).
Time frame: baseline, 8 weeks weeks.
Assessment of QUICKI index at baseline and after 8 weeks of intervention.
Change in Raynaud's index.
Time frame: baseline, 8 weeks weeks.
Assessment of Raynaud's index at baseline and after 8 weeks of intervention.
Change in McAuley Index.
Time frame: baseline, 8 weeks weeks.
Assessment of McAuley Index at baseline and after 8 weeks of intervention.

25 secondary outcomes

Change in glucose concentration.
Time frame: baseline, 8 weeks.
Change in insulin concentration.
Time frame: baseline, 8 weeks.
Change in homeostasis model assessment of insulin resistance index (HOMA-IR).
Time frame: baseline, 8 weeks.
Change in homeostasis model assessment of β-cell function index (HOMA-B).
Time frame: baseline, 8 weeks.
Change in menstrual cycle abnormalities.
Time frame: up to 8 weeks.
Change in hirsutism score
Time frame: baseline, 8 weeks.
Change in free testosterone concentration
Time frame: baseline, 8 weeks.
Change in serum concentration of follicle-stimulating hormone (FSH)
Time frame: baseline, 8 weeks or the next spontaneous menstrual cycle depending on menstrual cycle status.
Change in serum concentration of luteinizing hormone (LH) .
Time frame: baseline, 8 weeks or the next spontaneous menstrual cycle depending on menstrual cycle status.
Change in serum concentration of Insulin-like growth factor-1 (IGF-1).
Time frame: baseline, 8 weeks.
Change in serum concentration of Insulin-like growth factor binding protein-1 (IGFBP-1).
Time frame: baseline, 8 weeks.
Change in IGF-1 to IGFBP-1 ratio.
Time frame: baseline, 8 weeks.
Change in lipid profile.
Time frame: baseline, 8 weeks.
Change in serum concentration of C-reactive protein (CRP)
Time frame: baseline, 8 weeks.
Change in Body mass index (BMI).
Time frame: baseline, 8 weeks.
Change in waist circumference.
Time frame: baseline, 8 weeks.
Change in Hip circumference.
Time frame: baseline, 8 weeks.
Change in waist to hip ratio.
Time frame: baseline, 8 weeks.
Change in calcium concentration.
Time frame: baseline, 8 weeks.
Change in 25-OH-vitamin D concentration.
Time frame: baseline, 8 weeks.
Change in phosphorus concentration.
Time frame: baseline, 8 weeks.
Change in alanine transaminase (ALT) concentration.
Time frame: baseline, 8 weeks.
Change in aspartate transaminase (AST) concentration.
Time frame: baseline, 8 weeks.
Change in urea concentration.
Time frame: baseline, 8 weeks.
Change in creatinine concentration.
Time frame: baseline, 8 weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
Background: PubMed 23789983Ameri P, Giusti A, Boschetti M, Murialdo G, Minuto F, Ferone D. Interactions between vitamin D and IGF-I: from physiology to clinical practice. Clin Endocrinol (Oxf). 2013 Oct;79(4):457-63. doi: 10.1111/cen.12268. Epub 2013 Aug 9.
Background: PubMed 17177140Hahn 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. doi: 10.1055/s-2006-948308.
Background: PubMed 24933120Irani M, Merhi Z. Role of vitamin D in ovarian physiology and its implication in reproduction: a systematic review. Fertil Steril. 2014 Aug;102(2):460-468.e3. doi: 10.1016/j.fertnstert.2014.04.046. Epub 2014 Jun 3.
Background: PubMed 24044903Krul-Poel YH, Snackey C, Louwers Y, Lips P, Lambalk CB, Laven JS, Simsek S. The role of vitamin D in metabolic disturbances in polycystic ovary syndrome: a systematic review. Eur J Endocrinol. 2013 Oct 23;169(6):853-65. doi: 10.1530/EJE-13-0617. Print 2013 Dec.
Background: PubMed 21550088Li HW, Brereton RE, Anderson RA, Wallace AM, Ho CK. Vitamin D deficiency is common and associated with metabolic risk factors in patients with polycystic ovary syndrome. Metabolism. 2011 Oct;60(10):1475-81. doi: 10.1016/j.metabol.2011.03.002. Epub 2011 May 6.
Background: PubMed 22330149Ott J, Wattar L, Kurz C, Seemann R, Huber JC, Mayerhofer K, Vytiska-Binstorfer E. Parameters for calcium metabolism in women with polycystic ovary syndrome who undergo clomiphene citrate stimulation: a prospective cohort study. Eur J Endocrinol. 2012 May;166(5):897-902. doi: 10.1530/EJE-11-1070. Epub 2012 Feb 13.
Background: PubMed 27186859Pal L, Zhang H, Williams J, Santoro NF, Diamond MP, Schlaff WD, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers E, Legro RS; Reproductive Medicine Network. Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Clin Endocrinol Metab. 2016 Aug;101(8):3027-35. doi: 10.1210/jc.2015-4352. Epub 2016 May 17.
Background: PubMed 20711952Parikh G, Varadinova M, Suwandhi P, Araki T, Rosenwaks Z, Poretsky L, Seto-Young D. Vitamin D regulates steroidogenesis and insulin-like growth factor binding protein-1 (IGFBP-1) production in human ovarian cells. Horm Metab Res. 2010 Sep;42(10):754-7. doi: 10.1055/s-0030-1262837. Epub 2010 Aug 13.
Background: PubMed 10487660Thierry van Dessel HJ, Lee PD, Faessen G, Fauser BC, Giudice LC. Elevated serum levels of free insulin-like growth factor I in polycystic ovary syndrome. J Clin Endocrinol Metab. 1999 Sep;84(9):3030-5. doi: 10.1210/jcem.84.9.5941.
Derived from this study: PubMed 31354810Kadoura S, Alhalabi M, Nattouf AH. Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Menstrual Cycle Abnormalities, Hormonal Profile, and IGF-1 System in Polycystic Ovary Syndrome Patients: A Randomized, Placebo-Controlled Clinical Trial. Adv Pharmacol Sci. 2019 Jul 1;2019:9680390. doi: 10.1155/2019/9680390. eCollection 2019.
Individual participant dataSharing planned: Undecided

Related trials for Polycystic Ovary Syndrome

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sally Kadoura, B Pharm, MD principal investigator

Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

Abdul Hakim Nattouf, MD, PhD study director

Professor at Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

Marwan Alhalabi, MD, PhD study director

Professor at Department of Embryology and Reproductive Medicine, Faculty of Medicine, Damascus University, Damascus, Syria.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D3, Calcium Carbonate and Metformin in people with Polycystic Ovary Syndrome and Vitamin D Deficiency/Insufficiency, run by Damascus University at 2 sites in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quantitative insulin sensitivity check index (QUICKI). (time frame: baseline, 8 weeks weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792984, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.