Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity

NCT00992797 | Unknown Phase 2

• 1 other identifier: AUS-KIB-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.

Conditions

Diabetes Mellitus Type 2; Hypovitaminosis D

Keywords

Insulin resistance; Insulin secretory dysfunction; Inflammation; Vascular stiffness

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp

  Before and after the 6 months intervention period

Secondary Outcomes (9)

• Insulin secretion measured with IVGTT

  At 0 and 6 months

• Physical activity/muscle strength

  At 0 and 6 months

• HbA1c and fasting glucose

  At 0, 3 and 6 months

• Arterial stiffness

  At 0 and 6 months

• Differences in inflammatory markers, endothelial function and bone specific laboratory markers.

  At 0, 3 and 6 months

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Other: Orange juice

Interventions

Cholecalciferol DRUG

Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D \< 100 nmol/L. If serum 25(OH)D \> 100 placebo will be given. The cholecalciferol will be given in orange juice.

Also known as: Vitamin D, ZymaD

Cholecalciferol

Orange juice OTHER

Orange juice at randomization day and at week 5.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD \< 25 nmol/l) vitamin D deficiency measured at Visit 1.
• Patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. All medication must be in stable doses during the 4 week lead-in period.
• HbA1c \< 11 % at Visit 1.
• Able to communicate in Norwegian.
• Men and women ≥ 18 years.
• Norwegian or South Asian ethnicity.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. All WOCBP must have negative serum or urine pregnancy test at enrollment, randomization, titration visit and final study assessment.
• Antihypertensive medication, lipid lowering drugs, oral contraceptives, hormone replacement therapy, multivitamin supplements and nutritional supplements are allowed if the subjects adhere to the same regimen during the study

You may not qualify if:

• Subjects not having type 2 diabetes.
• SBP ≥ 160 or DBP ≥ 95 at Visit 1.
• Significant renal disease or chronic renal impairment, GFR\< 30 ml/min.
• Significant liver disease or ASAT or ALAT \>3x UNL.
• Malignancy during the last five years.
• Hypercalcemia at Visit 1.
• A history of kidney stone disease
• WOCBP unwilling or unable to use an acceptable method to avoid pregnancy.
• Pregnant or breastfeeding women.
• Chronic inflammatory disease in active phase
• Long term (\>2 weeks) use of corticosteroids last 3 months
• Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study.
• Drug or alcohol abuse.
• BMI \> 45 kg/m2 or bariatric surgery (\<5 years).
• Anemia

Sponsors & Collaborators

• University Hospital, Aker: lead
• University of Oslo: collaborator

Study Sites (1)

Diabetes Laboratory, Oslo University Hospital Aker

Oslo, 0514, Norway

RECRUITING

Related Publications (1)

• Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3.

  PMID: 28468770 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Vitamin D Deficiency; Insulin Resistance; Inflammation

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Kåre I Birkeland, MD PhD

  Oslo University Hospital, Aker

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulseth Wium, MD

CONTACT

4722894745; diabeteslab@aus.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 9, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: November 3, 2009

Record last verified: 2009-11

Locations

NO (1)