NCT01855321

Brief Summary

This pilot study will investigate the effect of Vitamin D supplementation in improving glucose control with patients with poorly controlled diabetes and concurrent Vitamin D deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_1 type-2-diabetes

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

August 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

4.6 years

First QC Date

March 18, 2013

Last Update Submit

June 25, 2015

Conditions

Type 2 Diabetes

Keywords

uncontrolled diabetesvitamin D deficiency

Outcome Measures

Primary Outcomes (1)

  • Percentage of improvement in Glycemic control after Vitamin D therapy.

    We will measure glycemic control as change in %HbAlc and fasting blood glucose after 9 months of Vitamin D therapy.

    9 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

The placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.

Drug: Placebo

Interventions

Vitamin DDRUG

The cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.

Also known as: cholecalciferol
Vitamin D
PlaceboDRUG

The placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of type 2 diabetes (per ADA criteria), on antihyperglycemic medications for at least 6 months and
  • HbAlc value of 7.5%-10% 7-12%for at least 3 months prior to screening, and
  • deficiency level of serum 25 (OH) Vitamin D i.e. below20 25 ng/mL at time of screening, but normal serum calcium values of 8.5-10.5mg/dL and
  • on either angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blockade (ARB) antihypertensive medication

You may not qualify if:

  • Any subjects with history of end-stage renal disease or frank proteinuria on urinalysis
  • Any subjects with pregnancy at time of screening
  • Any subjects with history of or current hypercalcemia (serum calcium \> 10.5 mg/dL) or disease processes with underlying hypercalcemia pathology including hyperparathyroidism, nephrolithiasis, sarcoidosis, lung or bone malignancy
  • Any subjects with diagnosis of Vitamin D deficiency or insufficiency, previously treated or currently treated with any form of prescription doses of either 1,25(OH)2D3 or 25(OH)D3 supplements exceeding 1000 IU/day
  • Any subjects with malabsorption syndromes, nephrotic syndrome, or on medications that activate steroid or xenobiotic receptors which will interfere with absorption of Vitamin D supplements
  • Any subjects with history of serious neurologic or psychiatric disorders that would interfere with the conduct or completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Medical Plaza

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Vitamin D Deficiency

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Margaret Lo, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

May 16, 2013

Study Start

August 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

US(1)