[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04355572":3,"trial-entities:NCT04355572":115,"trial-summary:NCT04355572":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":49,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":81,"locations":84,"central_contacts":107,"overall_officials":111,"references":113,"see_also_links":114},"NCT04355572","2000028054","Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)","RECRUITING","2028-08-31","2026-08","2026-08-20","2026-09","Yale University","OTHER",true,"This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period","Patients referred to the pediatric endocrinology clinic or adolescent gynecology clinic at Yale New Haven Children Hospital with a primary complaint of hirsutism, acne, or amenorrhea and\u002For oligomenorrhea persisting 2 years after their menarche will be evaluated for polycystic ovarian syndrome through history, physical exam, pelvic ultrasound, and laboratory evaluation, to include androgen testing, thyroid testing, female hormone testing, and diabetic risk testing (this is standard of care). A vitamin D level will also be drawn. While vitamin D level is not currently part of the diagnostic algorithm for PCOS, it is not unreasonable to check in patients in which there is concern for an endocrine disorder. If the patient meets Rotterdam criteria and their serum vitamin D level is between 6 and 29 ng\u002FmL, the patient and their guardian(s) will be approached for inclusion in our study by the physician or dedicated research nursing staff.\n\nIf patient and guardian agree to participate and sign a consent \u002F assent form, the patient will then be randomized to receive vitamin D supplement versus placebo and will be followed for 6 months on their randomized replacement with repeat laboratory testing of AMH, vitamin D, lipid profile, glucose and insulin testing, androgen testing, and female hormone testing at the randomization, 3 months and at the end of the course of the trial(6 months). Patients with vitamin D levels 5ng\u002FmL or less will not be randomized, they will be given recommended treatment. Depressive symptoms will be assessed at time of randomization, 3 months post randomization, and 6 months post randomization using the Beck Depression Inventory-II, the gold standard self-report depression inventory. A depression screen is currently administered to all adolescents seen at Yale New Haven Children Hospital outpatient clinics with a protocol for patients who report clinically significant levels of depression. This protocol will remain in place and will not be altered during this research study.\n\nAfter post-trial testing, patients will be unblinded and patients who still have vitamin D below threshold will be offered vitamin D treatment.\n\nAim 1: To investigate the effect of vitamin D replacement upon biochemical parameters of polycystic ovarian syndrome (PCOS) in adolescent female patients. Hypothesis: Replacement of vitamin D to normal levels in adolescents with PCOS and\u002For at risk for PCOS and low levels of vitamin D will lower serum androgen and anti-mullerian hormone (AMH) levels.\n\nAim 2: To investigate the effect of vitamin D replacement on clinical features of PCOS in adolescent female patients. Hypothesis: Replacement of vitamin D in adolescents with PCOS and\u002For at risk for PCOS and low levels of vitamin D will improve symptoms of menstrual irregularities, acne, and hirsutism.\n\nAim3: To investigate the effect of vitamin D replacement on depressive symptoms in adolescent female patients with PCOS. Hypothesis: Replacement of vitamin D in adolescents with PCOS or at risk for PCOS and low levels of serum vitamin D will improve symptoms of depression.",[18,19],"Polycystic Ovarian Syndrome in Adolescent Females","Vitamin D Deficiency",[21],"Anti-Mullerian Hormone (AMH)","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},60,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Vitamin D 4000IU daily","Randomized to receive vitamin D 4000IU daily",[35],"Vitamin D Supplement",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Placebo","Randomized to placebo daily",[37],[41,45],{"measure":42,"description":43,"timeFrame":44},"Change in oligomenorrhea","The change in oligomenorrhea, i.e restoration of monthly menses or improvement in the menstrual pattern during 6 months while enrolled in the trial based on self report","6 months",{"measure":46,"description":47,"timeFrame":48},"Changes Vitamin D (25-hydroxyvitamin D) level","25-hydroxyvitamin D level will be measured by liquid chromatography-mass spectrometry (LC-MS\u002FMS) or immunoassay","at enrollment, at 3 months after randomization and 6 months after randomization",[50,53,56,59,62,65,68],{"measure":51,"description":52,"timeFrame":48},"Change in DHEAS level","The serum DHEA-S concentration is the traditional marker for adrenal androgen excession because it is produced almost exclusively by the adrenal glands and concentrations remain stable across the day and cycle. Preferred testing is done by immunoassay.",{"measure":54,"description":55,"timeFrame":48},"Changes in Androstenedione level","Androstenedione concentration assesses for hyperandrogenemia as well, it is produced by the ovary and the adrenal cortex and serves as precursor of testosterone. Data suggests that levels are elevated in approximately 20% of women with PCOS. Evaluation is done by Liquid Chromatography\u002FTandem Mass Spectrometry",{"measure":57,"description":58,"timeFrame":48},"Change in Anti-Mullerian hormone (AMH) level","AMH is a dimeric glycoprotein of the transforming growth factor-β superfamily that is involved in growth and differentiation of ovarian follicles. AMH is expressed in granulosa cells in the ovary and serves as a marker of ovarian reserve as well as marker of several ovarian pathologies such as PCOS, granulosa cell tumors and premature ovarian insufficiency. Level will be measured using Immunoassay (IA)",{"measure":60,"description":61,"timeFrame":48},"Change in testosterone level","Testosterone levels are elevated in vast majority of adolescents with PCOS. The free testosterone level is more sensitive for diagnosis of hyperandrogenic disorders compared with the total testosterone. Evaluation is done by Chromatography\u002FMass Spectrometry",{"measure":63,"description":64,"timeFrame":48},"Change in Hirsutism","Hirsutism is defined as excessive male-pattern facial and body hair. This will be measured by using the modified Ferriman Gallwey score by a provider with scores of less than 6 indicating no evidence of hirsutism, 6-8 indicating mild hirsutism, scores 8-15 indicating moderate hirsutism and scores greater than 15 indicating severe hirsutism.",{"measure":66,"description":67,"timeFrame":48},"Change Body Acne","European Dermatology Forum Guidelines group (2011) grading system will be used to describe acne in 4 areas of the body- face, upper chest, upper back, upper arms: minimal - comedonal acne, mild to moderate: moderate papulopustular acne, severe: severe papulopustular acne, moderate nodular acne; severe nodular acne,conglobate acne",{"measure":69,"description":67,"timeFrame":48},"Change in Facial","FEMALE","13 Years","21 Years",false,{"inclusion":75,"exclusion":76,"raw_text":80},[],[77,78,79],"Other causes for hyperandrogenism,","Chronic renal diseases,","Acquired or inherited calcium and vitamin D metabolic disorders.","Inclusion Criteria:\n\n\\- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng\u002FmL.\n\nExclusion Criteria:\n\n* Other causes for hyperandrogenism,\n* Chronic renal diseases,\n* Acquired or inherited calcium and vitamin D metabolic disorders.",[82,83],"CHILD","ADULT",[85],{"facility":86,"status":7,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":104},"Yale New Haven Children's Hospital","New Haven","Connecticut","06510","United States",[92,97,101],{"name":93,"role":94,"phone":95,"email":96},"Alla Vash-Margita, Principal Investigator, MD","CONTACT","203-785-7409","alla.vash-margita@yale.edu",{"name":98,"role":94,"phone":99,"email":100},"Kathleen Miclette, nurse coordinator, RN","203-444-3720","kathleen.miclette@ynhh.org",{"name":102,"role":103},"Alla Vash-Margita, Associate Professor, MD","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},41.30815,-72.92816,[108],{"name":109,"role":94,"phone":110,"email":96},"Alla Vash-Margita, MD","203-785-4010",[112],{"name":109,"affiliation":12,"role":103},[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117,19],"Polycystic Ovary Syndrome",[119],"Ergocalciferol",{"nct_id":4,"found":14,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is a double-blind, placebo-controlled, randomized study, meaning neither you nor the study team will know if you are receiving Vitamin D 4000IU daily or the placebo. It plans to include 60 participants.","completed","Vitamin D Replacement for Adolescent Females with PCOS","This study is looking at how vitamin D affects adolescent females (ages 13-21) who have Polycystic Ovarian Syndrome (PCOS) and low vitamin D levels. PCOS is a common hormone problem that can cause irregular periods, acne, and excess hair growth. Participants will receive either Vitamin D 4000IU daily or a placebo (an inactive pill) for 6 months. Researchers want to see if Vitamin D 4000IU daily can improve irregular periods and increase vitamin D levels. To join, you must be a female between 13 and 21, have PCOS, and have a vitamin D level between 6-29 ng\u002FmL. The study aims to enroll 60 participants.","You will be followed for 6 months after starting the treatment.",104,"You would be followed for 6 months, with repeat blood tests at the start, 3 months, and 6 months. These tests include vitamin D, hormone levels, and blood sugar checks.","Not stated in the trial record.",[32,37],"v2"]