NCT01185574

Brief Summary

This study will examine whether weekly vitamin D supplementation in women with significant depressive symptoms and diabetes will exhibit improved mood and metabolic control. If supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method for treatment. Women will be targeted since they have greater depression and worse metabolic control than men with diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2.6 years

First QC Date

August 18, 2010

Last Update Submit

July 10, 2013

Conditions

Depressive SymptomsDiabetes

Outcome Measures

Primary Outcomes (1)

  • Metabolic control

    6 months

Secondary Outcomes (1)

  • depressive symptoms

    6 months

Study Arms (1)

Vitamin D supplementation

EXPERIMENTAL

The study medication (a capsule of 50,000 IU of vitamin D2) will be administered once a week for six months.

Dietary Supplement: Vitamin D supplementation

Interventions

Vitamin D supplementationDIETARY_SUPPLEMENT

Vitamin D2 50,000 IU will be administered once a week for six months.

Also known as: Drisdol
Vitamin D supplementation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 and older
  • medically stable type 2 diabetes with HBA1c \<9%.
  • significantly elevated depressive symptoms as measured by a score greater than or equal to 14 using the Center for Epidemiologic Studies Depression Tool (CES-D.

You may not qualify if:

  • vitamin D levels of 32 ng/dl or greater
  • malabsorption problems (e.g., crohn's disease, celiac sprue)
  • hypercalcemia-level greater than 10.5 mg/dl
  • Severe complications of diabetes (amputation, blindness, or renal problems) 5) Women with low thyroid function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

DepressionDiabetes Mellitus

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 20, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(1)