NCT01477034

Brief Summary

Chronic, low-grade adipose tissue inflammation is a major risk factor for type 2 diabetes mellitus. The cause of adipose tissue inflammation has remained largely unclear. We hypothesize that vitamin D deficiency predisposes individuals to the development of adipose tissue inflammation, and that treatment of vitamin D deficient subjects with high dose vitamin D will reduce adipose tissue inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

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

First Submitted

Initial submission to the registry

November 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

November 1, 2011

Last Update Submit

April 2, 2014

Conditions

Vitamin D DeficiencyObesityType 2 Diabetes MellitusIntestinal Permeability

Keywords

Vitamin D deficiencyObesityInflammationLow-grade, chronic inflammationAdipose tissue inflammationDiabetesType 2 diabetes mellitusInsulin resistanceIntestinal permeability

Outcome Measures

Primary Outcomes (2)

  • Tumor Necrosis Factor alpha expression in adipose tissue

    Total RNA will be extracted from whole adipose tissue. TNF alpha mRNA will be quantified using PCR, and normalized using a normalization factor based on three housekeeping genes. We will compute the change in adipose tissue TNF alpha mRNA level between baseline and the 6 month visit.

    Change from baseline to the 6 month visit

  • Tumor Necrosis Factor alpha expression in adipose tissue

    Total RNA will be extracted from whole adipose tissue. TNF alpha mRNA will be quantified using PCR, and normalized using a normalization factor based on three housekeeping genes. We will compute the change in adipose tissue TNF alpha mRNA level between baseline and the 3 month visit.

    Change from baseline to the 3 month visit

Secondary Outcomes (22)

  • Plasma concentrations of 24,25-dihydroxy vitamin D [24,25(OH)2D]

    Change from baseline to the 6 month visit

  • Adipose tissue concentration of 25-hydroxy vitamin D [25(OH)D]

    Change from baseline to the 6 month visit

  • CD16+ macrophages in adipose tissue

    Change from baseline to the 6 month visit

  • CD8+ T cells in adipose tissue

    Change from baseline to the 6 month visit

  • Plasma concentration of 25-hydroxy vitamin D [25(OH)D]

    Change from baseline to the 6 month visit

  • +17 more secondary outcomes

Study Arms (4)

2,000 IU/day vitamin D3 x 6 months

EXPERIMENTAL

Subjects will take a 2,000 IU daily vitamin D3 supplement for 6 months.

Dietary Supplement: Vitamin D3

4,000 IU/day vitamin D3 x 6 months

EXPERIMENTAL

Subjects will take a 4,000 IU daily vitamin D3 supplement for 6 months.

Dietary Supplement: Vitamin D3

2,000 IU/day vitamin D3 x 3 months

EXPERIMENTAL

Subjects will take a 2,000 IU daily vitamin D3 supplement for 3 months.

Dietary Supplement: Vitamin D3

4,000 IU/day vitamin D3 x 3 months

EXPERIMENTAL

Subjects will take a 4,000 IU daily vitamin D3 supplement for 3 months.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

2,000 or 4,000 IU/day vitamin D3 for 3 or 6 months.

Also known as: Carlson Labs Vitamin D3 capsules (2,000/4,000 IU/capsule)
2,000 IU/day vitamin D3 x 3 months2,000 IU/day vitamin D3 x 6 months4,000 IU/day vitamin D3 x 3 months4,000 IU/day vitamin D3 x 6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-65 years;
  • BMI ≥25 kg/m2;
  • Plasma 25-OH-vitamin D between 7 and 20 ng/mL
  • Weight stable to within 10 pounds for 6 months prior to entering the study, and within 30 pounds of their lifetime maximum weight (excluding pregnancy);
  • Ability to be admitted for \~6.5 hours on three occasions to the FHCRC Prevention Center,
  • Ability to provide informed written consent;
  • Willingness to take vitamin D3 capsules daily for 6 months

You may not qualify if:

  • Chronic disease such as thyroid disease, liver disease, or kidney disease;
  • Diabetes mellitus, or fasting glucose \>125 mg/dL;
  • Chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease;
  • Malabsorption syndromes (untreated celiac disease; condition after stomach or intestinal resection);
  • Current or recent (within one month) chronic intake of medications likely to interfere with study endpoints \[(insulin, antidiabetics, anabolic steroids, glucocorticosteroids, statins, blood thinners (warfarin, aspirin), non-steroidal anti-inflammatory drugs (if daily)\];
  • Current or recent (within 3 months) intake of vitamin D in excess of 600 IU/day;
  • Anemia, recent history (within 3 months) of anemia; recent (within 3 months) blood donation; recent (within 3 months) participation in another study that involved blood draws; or plans to participate in other research that involves blood draws during the study period;
  • Pregnancy in the last 6 months, plans to become pregnant during the study period, or current breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Best CM, Riley DV, Laha TJ, Pflaum H, Zelnick LR, Hsu S, Thummel KE, Foster-Schubert KE, Kuzma JN, Cromer G, Larson I, Hagman DK, Heshelman K, Kratz M, de Boer IH, Hoofnagle AN. Vitamin D in human serum and adipose tissue after supplementation. Am J Clin Nutr. 2021 Jan 4;113(1):83-91. doi: 10.1093/ajcn/nqaa295.

    PMID: 33184642DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyObesityDiabetes Mellitus, Type 2InflammationDiabetes MellitusInsulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPathologic ProcessesHyperinsulinism

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Mario Kratz, Ph.D.

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Member

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 22, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

US(1)