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Effects of vitamin D supplementation in type 1 diabetes mellitus patients

Effects of vitamin D supplementation in type 1 diabetes mellitus patients: a non-randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32601947
Enrollment
120
Registered
2017-07-31
Start date
2015-02-15
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus (DM1) Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus (DM1)

Interventions

All participants attend three scheduled study visits. At the first visit, participants undergo a physical examination, have blood samples taken and have a continuous glucose monitoring system (CGMS) f

Sponsors

Federal University of Pará
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of type 1 diabetes mellitus 2. Aged between 18 and 50 years 3. Regular follow-up with an Endocrinologist 4. HbA1c =7% 5. Treatment with basal-bolus insulin (multiple daily injections) at a stable dose for at least 3 months prior visit 1 (variation of up to 10% of dose was permitted)

Exclusion criteria

Exclusion criteria: 1. Previous and concomitant history of metabolic bone diseases, liver disease, abnormal glomerular filtration rate (GFR) levels 2. Patients that made use of vitamin D or calcium within the last 3 months

Design outcomes

Primary

MeasureTime frame
Glycemic variability is assessed using continuous glucose monitoring from baseline to three months

Secondary

MeasureTime frame
1. Vitamin D (25(OH)D) levels are measured by immonoassay on blood samples collected at baseline and three months 2. Albuminuria levels are measured by immunoturbidimetry at baseline and three months 3. Autonomic cardiovascular neuropathy is measured by physical examination and ECG at baseline and three months

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026