CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 265 enrolled
Drug / intervention
Vitamin D3 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01904032
NCT01904032Phase 2Completed

Vitamin D Supplement to Women With Type 2 Diabetes

Loyola University·interventional·Posted Jul 22, 2013·Updated Apr 26, 2022

In Brief

A Phase 2 clinical trial evaluating Vitamin D3 and Vitamin D3 comparator for Diabetes and 2 related conditions. Completed, enrolled 265 participants across 1 site.

Detailed Summary

This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3 supplementation on depressive symptoms, self-management, and blood pressure in approximately 180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting adult women who are eligible to participate will be randomly assigned to either a weekly dose of 50,000 international units of vitamin D3 supplementation or a matching weekly active comparator of 5,000 international units of vitamin D3 for six months. Participants will complete approximately four in-person study visits and several telephone visits throughout the six month trial period, where the researchers will assess depressive symptoms, diabetes self-management, and systolic blood pressure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 22, 2013
Enrollment StartNov 21, 2013
Primary CompletionNov 11, 2017
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 12.9 years ago

Interventions

Vitamin D3drug

50,000 international units (IUs) weekly Vitamin D3

Vitamin D3 comparatordrug

5,000 international units (IUs) of a weekly Vitamin D3 comparator