Vitamin D DeficiencyNCT01477034

Vitamin D and Adipose Tissue Inflammation

A study testing Vitamin D3 in people with Vitamin D Deficiency and Obesity, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Vitamin D Deficiency, Obesity, Type 2 Diabetes Mellitus
What is being tested?: Vitamin D3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Nov 2011to Jun 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109

Other trials in United States

About this study

Read the detailed description

The objective of this project is to investigate whether vitamin D modulates chronic low-grade adipose tissue inflammation in overweight and obese, vitamin D deficient men and women.

Obesity is associated with insulin resistance and an increased risk for type 2 diabetes mellitus. Numerous studies, mostly conducted in mouse models of obesity, strongly suggest that chronic low-grade inflammation of adipose and other tissues is the major mechanism by which increased adiposity is linked to insulin resistance. Adipose tissue inflammation may therefore be a promising therapeutic target to reduce insulin resistance and the risk of type 2 diabetes mellitus in obese individuals.

Based on several lines of evidence, we hypothesize that vitamin D is an environmental factor that affects the course of the inflammatory response in most tissues of the body, including adipose tissue. In our previous studies, we found that circulating plasma concentrations of 25-hydroxy vitamin D (25-OH-D) and the primary degradation product 24,25-dihydroxy vitamin D (24,25-OH2-D) were significantly associated with adipose tissue expression of adiponectin and negatively with TNF-alpha, even when adjusted for body mass index. Because these previous studies were cross-sectional, it is critical to complete an intervention study in humans to determine whether the observed association of vitamin D levels and adipose tissue inflammation is causal. The objectives of this pilot study are therefore to collect relevant preliminary data, and to begin an exploration of the mechanisms underlying this association such as intestinal permeability.

Increased intestinal permeability may contribute to chronic low-grade inflammation and signaling through the vitamin D receptor plays an important role in the maintenance of intestinal integrity. We will assess whether normalization of vitamin D status is associated with changes in intestinal permeability.

Conditions: Vitamin D Deficiency, Obesity, Type 2 Diabetes Mellitus, Intestinal Permeability
Being tested: Vitamin D3
Keywords: Vitamin D deficiency, Obesity, Inflammation, Low-grade, chronic inflammation, Adipose tissue inflammation, Diabetes, Type 2 diabetes mellitus, Insulin resistance, Intestinal permeability
Medical subject headings: Vitamin D Deficiency, Obesity, Diabetes Mellitus, Type 2, Inflammation, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Dietary supplement
Also called Carlson Labs Vitamin D3 capsules (2,000/4,000 IU/capsule)
2,000 or 4,000 IU/day vitamin D3 for 3 or 6 months.

Study groups in NCT01477034
Study group	Role	What they receive
2,000 IU/day vitamin D3 x 6 months	Experimental	Subjects will take a 2,000 IU daily vitamin D3 supplement for 6 months. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Vitamin D3

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Change from baseline to the 3 month visit

Secondary outcomes (22)

Plasma concentrations of 24,25-dihydroxy vitamin D [24,25(OH)2D]
The concentration of 24,25(OH)2D will be measured in fasting plasma using high performance liquid chromatography-tandem mass spectometry (LC/MS/MS).
Measured: Change from baseline to the 6 month visit
Adipose tissue concentration of 25-hydroxy vitamin D [25(OH)D]
Adipose tissue 25(OH)D will be measured using high performance liquid chromatography-tandem mass spectometry (LC/MS/MS.)
Measured: Change from baseline to the 6 month visit
CD16+ macrophages in adipose tissue
The number or CD16+ macrophages in adipose tissue, normalized to the total number of CD14+CD206+ macrophages or the total number of CD45+ cells, will be measured using multi-parameter flow cytometry.
Measured: Change from baseline to the 6 month visit
CD8+ T cells in adipose tissue
The number of CD8+ T cells in adipose tissue, normalized to the total number of CD3+ cells, will be measured using multi-parameter flow cytometry.
Measured: Change from baseline to the 6 month visit
Plasma concentration of 25-hydroxy vitamin D [25(OH)D]
Plasma 25(OH)D will be measured by high performance liquid chromatography-tandem mass spectometry (LC/MS/MS).
Measured: Change from baseline to the 6 month visit
Adipose tissue concentration of cholecalciferol (vitamin D3)
Adipose tissue concentrations of cholecalciferol will be measured by high performance liquid chromatography-tandem mass spectometry (LC/MS/MS)
Measured: Change from baseline to the 6 month visit
CD11c+ macrophages in adipose tissue
The number of CD11c+ macrophages in adipose tissue, normalized to the total number of CD45+ cells, will be measured by multi-parameter flow cytometry.
Measured: Change from baseline to the 6 month visit
CD4+CD25+ T cells in adipose tissue
The number of CD4+CD25+ T cells in adipose tissue, normalized to the total number of CD4+ T cells, will be measured by multi-parameter flow cytometry.
Measured: Change from baseline to the 6 month visit
Intestinal permeability, as assessed by the 5-hour urinary lactulose/mannitol test
Intestinal permeability will be assessed at each clinic visit by administering 2g of mannitol and 5 g of lactulose to the oral glucose tolerance test beverage followed by collection of urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability.
Measured: Change from baseline to 6 month clinic visit.
Fasting plasma zonulin concentrations
Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected at all clinic visits. Plasma zonulin is a marker of intestinal permeability.
Measured: Change from baseline to 6 month clinic visit
Fasting plasma lipopolysaccharide binding protein (LBP)
Lipopolysaccharide binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected at all clinic visits. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure.
Measured: Change from baseline to 6 month clinic visit
Plasma concentrations of 24,25-dihydroxy vitamin D [24,25(OH)2D]
The concentration of 24,25(OH)2D will be measured in fasting plasma using high performance liquid chromatography-tandem mass spectometry (LC/MS/MS).
Measured: Change from baseline to the 3 month visit
Adipose tissue concentration of 25-hydroxy vitamin D [25(OH)D]
Adipose tissue 25(OH)D will be measured using high performance liquid chromatography-tandem mass spectometry (LC/MS/MS.)
Measured: Change from baseline to the 3 month visit
CD16+ macrophages in adipose tissue
The number or CD16+ macrophages in adipose tissue, normalized to the total number of CD14+CD206+ macrophages or the total number of CD45+ cells, will be measured using multi-parameter flow cytometry.
Measured: Change from baseline to the 3 month visit
CD8+ T cells in adipose tissue
The number of CD8+ T cells in adipose tissue, normalized to the total number of CD3+ cells, will be measured using multi-parameter flow cytometry.
Measured: Change from baseline to the 3 month visit
Plasma concentration of 25-hydroxy vitamin D [25(OH)D]
Plasma 25(OH)D will be measured by high performance liquid chromatography-tandem mass spectometry (LC/MS/MS).
Measured: Change from baseline to the 3 month visit
Adipose tissue concentration of cholecalciferol (vitamin D3)
Adipose tissue concentrations of cholecalciferol will be measured by high performance liquid chromatography-tandem mass spectometry (LC/MS/MS)
Measured: Change from baseline to the 3 month visit
CD11c+ macrophages in adipose tissue
The number of CD11c+ macrophages in adipose tissue, normalized to the total number of CD45+ cells, will be measured by multi-parameter flow cytometry.
Measured: Change from baseline to the 3 month visit
CD4+CD25+ T cells in adipose tissue
The number of CD4+CD25+ T cells in adipose tissue, normalized to the total number of CD4+ T cells, will be measured by multi-parameter flow cytometry.
Measured: Change from baseline to the 3 month visit
Intestinal permeability, as assessed by the 5-hour urinary lactulose/mannitol test
Intestinal permeability will be assessed at each clinic visit by administering 2g of mannitol and 5 g of lactulose to the oral glucose tolerance test beverage followed by collection of urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability.
Measured: Change from baseline to 3 month clinic visit.
Fasting plasma zonulin concentrations
Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected at all clinic visits. Plasma zonulin is a marker of intestinal permeability.
Measured: Change from baseline to 3 month clinic visit
Fasting plasma lipopolysaccharide binding protein (LBP)
Lipopolysaccharide binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected at all clinic visits. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure.
Measured: Change from baseline to 3 month clinic visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jun 2013

First posted22 Nov 2011 (estimated)
Study startNov 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01477034
Sponsor's protocol ID: UW NORC P&F KRATZ
Other IDs: 7598
Status last verified: Apr 2014
First submitted: 1 Nov 2011
Last updated: 4 Apr 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 33184642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
RecruitingPhase 3
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Vision Loss Night, Vision Disorders
Active, not recruitingPhase 3
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Critical Illness, Vitamin D Deficiency

All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D and Adipose Tissue Inflammation
ClinicalTrials.gov ID: NCT01477034
Acronym / sponsor ID: UW NORC P&F KRATZ
Conditions: Vitamin D Deficiency, Obesity, Type 2 Diabetes Mellitus, Intestinal Permeability
Keywords: Vitamin D deficiency, Obesity, Inflammation, Low-grade, chronic inflammation, Adipose tissue inflammation, Diabetes, Type 2 diabetes mellitus, Insulin resistance
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: University of Washington
Study start: Nov 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 22 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The objective of this project is to investigate whether vitamin D modulates chronic low-grade adipose tissue inflammation in overweight and obese, vitamin D deficient men and women.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
2,000 IU/day vitamin D3 x 6 months	Experimental	Dietary Supplement: Vitamin D3Subjects will take a 2,000 IU daily vitamin D3 supplement for 6 months.
4,000 IU/day vitamin D3 x 6 months	Experimental	Dietary Supplement: Vitamin D3Subjects will take a 4,000 IU daily vitamin D3 supplement for 6 months.
2,000 IU/day vitamin D3 x 3 months	Experimental	Dietary Supplement: Vitamin D3Subjects will take a 2,000 IU daily vitamin D3 supplement for 3 months.
4,000 IU/day vitamin D3 x 3 months	Experimental	Dietary Supplement: Vitamin D3Subjects will take a 4,000 IU daily vitamin D3 supplement for 3 months.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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,

Key exclusion criteria (8 listed)

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)];

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3Also: Carlson Labs Vitamin D3 capsules (2,000/4,000 IU/capsule)2,000 or 4,000 IU/day vitamin D3 for 3 or 6 months.	Dietary supplement	2,000 IU/day vitamin D3 x 3 months, 2,000 IU/day vitamin D3 x 6 months, 4,000 IU/day vitamin D3 x 3 months, 4,000 IU/day vitamin D3 x 6 months

Primary outcome

Tumor Necrosis Factor alpha expression in adipose tissue
Time frame: Change from baseline to the 6 month visit
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.
Tumor Necrosis Factor alpha expression in adipose tissue
Time frame: Change from baseline to the 3 month visit
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.

22 secondary outcomes

Plasma concentrations of 24,25-dihydroxy vitamin D [24,25(OH)2D]
Time frame: Change from baseline to the 6 month visit
Adipose tissue concentration of 25-hydroxy vitamin D [25(OH)D]
Time frame: Change from baseline to the 6 month visit
CD16+ macrophages in adipose tissue
Time frame: Change from baseline to the 6 month visit
CD8+ T cells in adipose tissue
Time frame: Change from baseline to the 6 month visit
Plasma concentration of 25-hydroxy vitamin D [25(OH)D]
Time frame: Change from baseline to the 6 month visit
Adipose tissue concentration of cholecalciferol (vitamin D3)
Time frame: Change from baseline to the 6 month visit
CD11c+ macrophages in adipose tissue
Time frame: Change from baseline to the 6 month visit
CD4+CD25+ T cells in adipose tissue
Time frame: Change from baseline to the 6 month visit
Intestinal permeability, as assessed by the 5-hour urinary lactulose/mannitol test
Time frame: Change from baseline to 6 month clinic visit.
Fasting plasma zonulin concentrations
Time frame: Change from baseline to 6 month clinic visit
Fasting plasma lipopolysaccharide binding protein (LBP)
Time frame: Change from baseline to 6 month clinic visit
Plasma concentrations of 24,25-dihydroxy vitamin D [24,25(OH)2D]
Time frame: Change from baseline to the 3 month visit
Adipose tissue concentration of 25-hydroxy vitamin D [25(OH)D]
Time frame: Change from baseline to the 3 month visit
CD16+ macrophages in adipose tissue
Time frame: Change from baseline to the 3 month visit
CD8+ T cells in adipose tissue
Time frame: Change from baseline to the 3 month visit
Plasma concentration of 25-hydroxy vitamin D [25(OH)D]
Time frame: Change from baseline to the 3 month visit
Adipose tissue concentration of cholecalciferol (vitamin D3)
Time frame: Change from baseline to the 3 month visit
CD11c+ macrophages in adipose tissue
Time frame: Change from baseline to the 3 month visit
CD4+CD25+ T cells in adipose tissue
Time frame: Change from baseline to the 3 month visit
Intestinal permeability, as assessed by the 5-hour urinary lactulose/mannitol test
Time frame: Change from baseline to 3 month clinic visit.
Fasting plasma zonulin concentrations
Time frame: Change from baseline to 3 month clinic visit
Fasting plasma lipopolysaccharide binding protein (LBP)
Time frame: Change from baseline to 3 month clinic visit

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
Derived from this study: PubMed 33184642Best 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.

Related trials for Vitamin D Deficiency

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
RecruitingPhase 3
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Vision Loss Night, Vision Disorders
Active, not recruitingPhase 3
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Critical Illness, Vitamin D Deficiency

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mario Kratz, Ph.D. principal investigator

Fred Hutchinson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 in people with Vitamin D Deficiency and Obesity, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Necrosis Factor alpha expression in adipose tissue (time frame: Change from baseline to the 6 month visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01477034, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014; AzTrials last refreshed its copy on 31 Oct 2026.