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TerminatedNCT02204527Updated Jan 26, 2017

Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension

An interventional study of supplementation of 100.000 IU of vitamin D3 and placebo pill in Hypertension, sponsored by Hospital de Clinicas de Porto Alegre. Terminated at 1 site in Brazil. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study summary

In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D supplementation in patients with type 2 diabetes and hypertension

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
  • diabetes mellitus
  • vitamin D
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • type 2 diabetes
  • hypovitaminosis D
  • hypertension

Exclusion criteria

Exclusion Criteria:

  • pregnant or lactating
  • patients using vitamin D supplementation
  • using drugs that interfere on vitamin D metabolism (corticosteroids, anticonvulsants)
  • illicit drug use
  • diseases such as chronic renal failure (serum creatinine greater than 2.0 mg/dl)
  • liver cirrhosis
  • alcoholism
  • dementia
  • malignant disease that compromises the 5-year survival,
  • digestive tract (malabsorption) diseases
  • BMI> 40 kg / m2
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    vitamin D3

    supplementation of 100.000 IU of vitamin D3

    Dietary Supplement: supplementation of 100.000 IU of vitamin D3

  • Placebo comparator
    Placebo pill

    Placebo

    Dietary Supplement: placebo pill

Interventions

  • Dietary supplementsupplementation of 100.000 IU of vitamin D3

    supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))

    Also known as: supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill)

  • Dietary supplementplacebo pill

    Placebo

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Ambulatory Blood pressure monitoring

    Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation

    Time frame: up to 24 hours

07

Study locations

1 site
  • HCPA, Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035903, Brazil
08

References and documents

Publications

  • de Paula TP, Moreira JSR, Sperb LF, Muller MEP, Steemburgo T, Viana LV. Efficacy of single-dose cholecalciferol in the blood pressure of patients with type 2 diabetes, hypertension and hypovitaminoses D. Sci Rep. 2020 Nov 12;10(1):19611. doi: 10.1038/s41598-020-76646-6. PubMed 33184328 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02204527
Lead sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
Responsible party
Mirela Jobim de Azevedo (Mirela Jobim Azevedo, Hospital de Clinicas de Porto Alegre) — Principal investigator
First posted
Jul 30, 2014
Start date
Oct 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 26, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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