NCT01736865

Brief Summary

This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 15, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 11, 2019

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

November 15, 2012

Results QC Date

December 1, 2017

Last Update Submit

March 23, 2020

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Disposition Index

    Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels.

    6 months

Secondary Outcomes (1)

  • Number of Participants With Change in Glycemia

    12 months

Other Outcomes (6)

  • Hemoglobin A1c

    12 months

  • Change in Diabetes Medications

    6 and 12 months

  • Variability of Response to Vitamin D Supplementation in Subgroups.

    Baseline and 12 months

  • +3 more other outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR

One placebo pill daily for 1 year

Drug: Placebo

cholecalciferol

ACTIVE COMPARATOR

One cholecalciferol pill daily for 1 year

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG
cholecalciferol
PlaceboDRUG
placebo

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established type 2 diabetes, defined by one of the following two criteria:
  • Age ≥ 25 years and ≤ 75 years
  • BMI: 23 to 40 kg/m2 inclusive
  • Provision of signed and dated written informed consent prior to any study procedures.

You may not qualify if:

  • "Severe" diabetes defined by one of the following criteria:
  • \- (a) Symptoms of hyperglycemia;
  • \- (b) Screening HbA1c ≥ 7.5 \[may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy\]
  • History of nephrolithiasis or hypercalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Location

Related Publications (3)

  • Meng H, Matthan NR, Angellotti E, Pittas AG, Lichtenstein AH. Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):538-547. doi: 10.1093/ajcn/nqaa149.

    PMID: 32559272DERIVED

  • Angellotti E, D'Alessio D, Dawson-Hughes B, Chu Y, Nelson J, Hu P, Cohen RM, Pittas AG. Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes. Clin Nutr. 2019 Oct;38(5):2449-2453. doi: 10.1016/j.clnu.2018.10.003. Epub 2018 Oct 9.

    PMID: 30352748DERIVED

  • Alzaman NS, Dawson-Hughes B, Nelson J, D'Alessio D, Pittas AG. Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation. Am J Clin Nutr. 2016 Jul;104(1):205-14. doi: 10.3945/ajcn.115.129478. Epub 2016 May 18.

    PMID: 27194308DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Anastassios Pittas
Organization
Tufts Medical Center
apittas@tuftsmedicalcenter.org
617-636-5694

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 29, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 1, 2020

Results First Posted

January 11, 2019

Record last verified: 2020-03

Locations

US(2)