NCT01240213

Brief Summary

Experimental and human data suggests that vitamin D could protect against breast cancer. Overweight/obese individuals are at increased risk of low vitamin D levels. Vitamin D may reduce production of fat tissue, thereby reducing weight gain, which would result in lower levels of adipose-derived hormones and other breast cancer risk factors.The purpose of this study is to test the effect of vitamin D supplementation on the response to a weight loss (diet + exercise) intervention and select breast cancer risk factors in overweight and obese postmenopausal women with low blood vitamin D levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

November 9, 2010

Last Update Submit

August 5, 2013

Conditions

Breast CancerObesityHypovitaminosis D

Keywords

Vitamin Dlifestyle interventionpostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • Compare the effects of a 1-year one year Vitamin D supplementation vs placebo, on weight loss in postmenopausal women following a weight loss diet and exercise program.

    One Year

Secondary Outcomes (5)

  • Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers (insulin,glucose,CRP) associated with increased breast cancer risk.

    One Year

  • Test 12-months vitamin D effects on muscle strength as measured by 1RM leg press and bench press in women undergoing weight loss.

    One Year

  • Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss.

    One Year

  • Effect of Vitamin D supplementation on breast epithelial cell cytomorphology

    One Year

  • Effect of Vitamin D on epithelial cell gene expression

    One year

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

2000 IU per day of Vitamin D

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

2000 IU per day of Vitamin D

Also known as: calciferol
Vitamin D
PlaceboDIETARY_SUPPLEMENT

1 Placebo per day

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-75 years
  • Postmenopausal (no periods for past 12 months)
  • Screening serum vitamin D (25(OH)D) between 10 and 32 ng/mL ("insufficient")
  • No menopausal HRT use of any type including vaginal X 6 months and willing to avoid use for study duration
  • BMI \> 25.0 kg/m2 (\> 23.0 for Asians)
  • Physically able to undertake a calorie reduction and exercise program
  • Able to come for clinic visits, classes, and measurements, fill out questionnaires and logs in English
  • Gives informed consent, agrees to be randomly assigned

You may not qualify if:

  • Currently using more that 400 IU vitamin D from supplemental sources
  • Screening vitamin D level \< 10 ng/mL (will be referred to primary provider) or \> 32 ng/mL (already sufficient)
  • Osteoporosis
  • Renal disease, history of kidney stones
  • Any contra-indications to taking vitamin D 2000 IU/day
  • Plans to leave the study area within the follow-up period
  • Plans to join another organized weight loss program or take appetite suppressant medication during the study period
  • History of bariatric surgery
  • Current use of medications likely to interfere with adherence to interventions or study outcomes
  • Current smoker
  • Personal history of invasive or in situ breast cancer
  • Personal history of invasive cancer other than breast: except for non- melanoma skin cancer which would be eligible
  • Diabetes mellitus
  • Abnormalities on screening physical that contraindicate participation
  • Severe congestive heart failure per NYHA criteria 3 \& 4
  • +3 more criteria

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 (4)

  • Mason C, de Dieu Tapsoba J, Duggan C, Wang CY, Korde L, McTiernan A. Repletion of vitamin D associated with deterioration of sleep quality among postmenopausal women. Prev Med. 2016 Dec;93:166-170. doi: 10.1016/j.ypmed.2016.09.035. Epub 2016 Sep 28.

    PMID: 27687537DERIVED

  • Mason C, Tapsoba JD, Duggan C, Imayama I, Wang CY, Korde L, McTiernan A. Effects of Vitamin D3 Supplementation on Lean Mass, Muscle Strength, and Bone Mineral Density During Weight Loss: A Double-Blind Randomized Controlled Trial. J Am Geriatr Soc. 2016 Apr;64(4):769-78. doi: 10.1111/jgs.14049. Epub 2016 Apr 5.

    PMID: 27060050DERIVED

  • Duggan C, de Dieu Tapsoba J, Mason C, Imayama I, Korde L, Wang CY, McTiernan A. Effect of Vitamin D3 Supplementation in Combination with Weight Loss on Inflammatory Biomarkers in Postmenopausal Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2015 Jul;8(7):628-35. doi: 10.1158/1940-6207.CAPR-14-0449. Epub 2015 Apr 23.

    PMID: 25908506DERIVED

  • Mason C, Xiao L, Imayama I, Duggan C, Wang CY, Korde L, McTiernan A. Vitamin D3 supplementation during weight loss: a double-blind randomized controlled trial. Am J Clin Nutr. 2014 May;99(5):1015-25. doi: 10.3945/ajcn.113.073734. Epub 2014 Mar 12.

    PMID: 24622804DERIVED

MeSH Terms

Conditions

Breast NeoplasmsObesityVitamin D Deficiency

Interventions

Vitamin DCholecalciferolSugars

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipidsCarbohydrates

Study Officials

  • Anne McTiernan, MD, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 15, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

US(1)