The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency

NCT01991054 | Completed Phase 4

• 1 other identifier: HGA1C vs D
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health. There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2 diabetes. The purpose of this study is to evaluate the effect of high dose vitamin D supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D deficient patients with non-optimally controlled type 2 diabetes mellitus.

Conditions

Diabetes Mellitus; Vitamin D Deficiency

Keywords

Diabetes mellitus; HgA1C; 25(OH) vitamin D; HgA1C levels above 7.5%

Outcome Measures

Primary Outcomes (1)

• Change in Hba1c (%) in study groups

  We assume that the treatment with vitamin D will improve diabetes control, as assessed by Hba1c . The expected reduction in Hba1c levels will be 0.5%.

  2 years

Secondary Outcomes (9)

• Lipid profile

  2 years

• C-reactive protein

  2 years

• Body Weight

  2 years

• Blood Pressure

  2 years

• serum calcium

  2 years

Study Arms (2)

vitamin D3 supplementation

EXPERIMENTAL

The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months

Dietary Supplement: vitamin D3

placebo group

PLACEBO COMPARATOR

placebo group, 15 ml per month for 6 months

Dietary Supplement: vitamin D3

Interventions

vitamin D3 DIETARY_SUPPLEMENT

Also known as: Cholecalciferol

placebo group; vitamin D3 supplementation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written inform consent must be obtained from the patient before any assessment is performed.
• Male or female patient, 18 years or older.
• Diabetes mellitus patients.
• HgA1C levels on randomization above 7.5% in the last 6 months.
• Low 25(OH) vitamin D levels : under 50nmol/l

You may not qualify if:

• Patient who are unable consume food orally.
• Life expectancy under 7 month.
• Unable to sign inform consent.
• Patient unwilling or unable to comply with study procedure.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek medical center, endocrone clinic

Afula, 1834111, Israel

Location

Related Publications (39)

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Related Links

• 41\. "Vitamin D and Calcium: Updated Dietary Reference Intakes". Nutrition and Healthy Eating. Health Canada. Retrieved 2012-06-13.
• 42\. U.S. Food and Drug Administration: Guidance for Industry: A Food labeling Guide.

MeSH Terms

Conditions

Diabetes Mellitus; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• avraham ishay, M.D

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: endocronologist

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 27, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)