Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Anxiety Disorders

Syndrome

Depression

Depressive Disorder

Mood Disorders

Polycystic Ovary Syndrome

Insulin Resistance

Vitamin D Deficiency

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Quality of Life

Hypoglycemic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Vitamins

Insulin

Insulin, Globin Zinc

Metformin

Vitamin D

Cholecalciferol

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Heather Huddleston, MD

Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.

This is a single center, open-label, randomized, pilot clinical trial. Women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin D insufficient are eligible. Subjects are randomly assigned to one of two interventions: Vitamin D versus metformin. Subjects are followed with questionnaires and a final wrap-up clinic visit with a physician. The study duration is 12 weeks.

Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial

Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial

BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.

STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score

Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated.

Reference ranges:

optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL

University of California, San Francisco

AE and SAE definition meet clinicaltrials.gov definitions

Investigators will carefully track serious adverse events and all of these events will be reported to the DSM at scheduled meetings. Grade 4 adverse events will be reported to the DSM within 24 hours of receipt by the Study Coordinator. Adverse events meeting IRB reporting criteria (adverse event that are definitely, probably, or possibly related to the research AND serious OR unexpected) will be reported within 5 working days.

Cholecalciferol 5,000 IU PO daily

Vitamin D: Oral medication daily

Vitamin D (Cholecalciferol)

Metformin 1000 mg PO bid

Metformin: Oral medication daily

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fasting blood insulin levels were assayed by Quest Diagnostics. Time point: Baseline, pre-intervention

Optimal Reference range:

Fasting 2.0-19.6 μIU/mL

Fasting Insulin

Fasting blood glucose levels were assayed by Quest Diagnostics. Time point: Baseline, pre-intervention

Optimal Reference range:

Fasting 65-99 mg/dL

Fasting Glucose

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnositcs.

Time point: Baseline, pre-intervention HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.

Fasting Insulin Resistance

Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Time period: baseline, pre-intervention

Reference ranges:

optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL

Vitamin D, 25 hydroxy

BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms.

Time period: baseline; pre-intervention

Score ranges:

{0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}.

Beck Depression Inventory (BDI-II)

STAI-S is a validated self-reported instrument of 20 questions. Time period: baseline, pre-intervention

Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms

State-Trait Anxiety Inventory Score (STAI-S)

Although 3 participants were assigned to Vitamin D, one dropped out just after enrollment and arm assigment and another dropped out after completing baseline time point measures, thus only one participant in the Vitamin D arm had data available for outcome measures analysis. Although 2 participants were assigned to Metformin, one dropped out just after enrollment and arm assignment, thus only one participant in the Metformin arm had data available for outcome measures analysis.

Feasibility of recruitment and participant completion determined to be too low to continue the study and the trial was terminated early, resulting in only 2 of the 5 enrolled participants completing the trial. This lead to only two subjects will full data and one subject with partial data being analyzed.

Heather Huddleston

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Depression from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 scores were available.

Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Insulin Resistance from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 serum insulin and glucose test results were available.

Changes From Baseline Week in Insulin Resistance Score at Week 12.

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for a Change in Anxiety scores from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 scores were available.

Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks

In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Vitamin D serum levels from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 serum Vitamin D test results were available.

Spots Global Cancer Trial Database for Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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