NCT02464462

Brief Summary

The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started May 2010

Longer than P75 for phase_1 type-2-diabetes-mellitus

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

June 3, 2015

Last Update Submit

June 4, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

serum calcidiolT2DMvitamin D3 supplementationpost-menopausal womenethnic diversecalcium supplementation

Outcome Measures

Primary Outcomes (1)

  • Serum calcidiol

    3 years

Secondary Outcomes (4)

  • Fasting insulin

    3 years

  • Parathyroid Hormone

    3 years

  • Fasting blood glucose

    3 years

  • Glycated Hemoglobin

    3 years

Study Arms (2)

CaD Group

EXPERIMENTAL

This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium

Dietary Supplement: vitamin D3 and calcium

Placebo Group

PLACEBO COMPARATOR

This arm received rice powder pills

Other: Placebo

Interventions

vitamin D3 and calciumDIETARY_SUPPLEMENT

1800 IU vitamin D3 plus 720 mg Calcium

CaD Group
PlaceboOTHER

Rice powder pills

Placebo Group

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Non-white, post menopausal female
  • Have access to Community Health Center

You may not qualify if:

  • neurodegenerative disease
  • kideny disease
  • gluten allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

CholecalciferolCalcium

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Progessor

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

May 1, 2010

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

June 8, 2015

Record last verified: 2015-06