Clinical trial · Interventional
Vitamin D, Diet and Activity Study
Vitamin D, Weight Loss, and Breast Cancer Biomarkers
NCT01240213CI-TRIAL-00011628ViDAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hypovitaminosis D | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vitamin D
- description
- 2000 IU per day of Vitamin D
- interventionNames
- Dietary Supplement: Vitamin D
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- 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.
- timeFrame
- One Year
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Contraindications for entry into a research exercise program: recent (within 6 months) myocardial infarction, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism, deep vein thrombosis, uncontrolled hypertension (systolic \> 200, diastolic \> 100), orthostatic hypotension, moderate/severe aortic stenosis, uncontrolled arrythmia, uncontrolled congestive heart failure, left bundle branch block, history of cardiac arrest or stroke
* Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
* For the RPFNA/adipose tissue substudy: bilateral breast cancer, bilateral mastectomy, unable or unwilling to stop aspirin or NSAIDs for 1 week before and after the procedure, allergy to anesthetics or local anesthetics.References
Publications (4)
- DERIVEDMason 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 27687537
- DERIVEDMason 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 27060050
- DERIVEDDuggan 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 25908506
- DERIVEDMason 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 24622804