Clinical trial NCT01736865: Vitamin D for Established Type 2 Diabetes (DDM2)
Official title: Vitamin D for Established Type 2 Diabetes (DDM2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-11-29
Enrollment: 127
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).


Eligibility criteria: Inclusion Criteria:

* Established type 2 diabetes, defined by one of the following two criteria:
* Age ≥ 25 years and ≤ 75 years
* BMI: 23 to 40 kg/m2 inclusive
* Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria

* "Severe" diabetes defined by one of the following criteria:
* - (a) Symptoms of hyperglycemia;
* - (b) Screening HbA1c ≥ 7.5 \[may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy\]
* History of nephrolithiasis or hypercalcemia

Primary outcomes:
measure: Disposition Index
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Change in Glycemia
timeFrame: 12 months
Other outcomes:
measure: Hemoglobin A1c
timeFrame: 12 months
measure: Change in Diabetes Medications
timeFrame: 6 and 12 months
measure: Variability of Response to Vitamin D Supplementation in Subgroups.
timeFrame: Baseline and 12 months
measure: Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration
timeFrame: 12 months
measure: Cardiovascular Risk Factors
timeFrame: 6 and 12 months
measure: Effect of Vitamin D Supplementation on Plasma Concentrations of Surrogate Biomarkers of Cholesterol Absorption (Campesterol and β-sitosterol) and Endogenous Synthesis (Lathosterol and Desmosterol)
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
Study officials:
References:
citation: Meng H, Matthan NR, Angellotti E, Pittas AG, Lichtenstein AH. Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):538-547. doi: 10.1093/ajcn/nqaa149.
citation: Angellotti E, D'Alessio D, Dawson-Hughes B, Chu Y, Nelson J, Hu P, Cohen RM, Pittas AG. Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes. Clin Nutr. 2019 Oct;38(5):2449-2453. doi: 10.1016/j.clnu.2018.10.003. Epub 2018 Oct 9.
citation: Alzaman NS, Dawson-Hughes B, Nelson J, D'Alessio D, Pittas AG. Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation. Am J Clin Nutr. 2016 Jul;104(1):205-14. doi: 10.3945/ajcn.115.129478. Epub 2016 May 18.