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

Diabetes Mellitus Clinical Trial

— VDD  

Official title:

A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991054
• Other study ID #: HGA1C vs D
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2013
• Last updated: February 26, 2018
• Start date: December 2013
• Est. completion date: January 2018

Study information

• Verified date: September 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, double blind, parallel group, clinical trial for 6 months duration.

The study group participants will receive vitamin D supplementation (120,000 IU per month) versus the placebo group for 6 months. glycemic control indexes will be measured in T2DM diagnosed study subjects.

Patient will be randomized 1:1 to one of two treatment groups. Vitamin D group vs placebo group.

Randomization kits will include either vitamin D or vitamin D placebo. Blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. Anthropometric measurements will be drawn as well, at the same time points.

Determination of sample size In order to find a 0.5 mean difference in HgA1C between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test).

ADMINISTRATIVE AND LEGAL OBLIGATIONS:

Individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties.

The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.

Source and study documents will be locked under the supervision of the PI- principle investigator for 15 years.

Study documentations and storage The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.

All persons authorized to make entries and/or correction on CRF will be included on the investigators team list delegation log.

Study printout and electronic CRF's, ICF's and other study documents will be stored in the at Haemek medical center under the supervision of the PI. All identifying details will be completely erased.

The investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D3

Locations

Country	Name	City	State
Israel	Haemek medical center, endocrone clinic	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (39)

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Knekt P, Laaksonen M, Mattila C, Härkänen T, Marniemi J, Heliövaara M, Rissanen H, Montonen J, Reunanen A. Serum vitamin D and subsequent occurrence of type 2 diabetes. Epidemiology. 2008 Sep;19(5):666-71. doi: 10.1097/EDE.0b013e318176b8ad. — View Citation

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Wang L, Song Y, Manson JE, Pilz S, März W, Michaëlsson K, Lundqvist A, Jassal SK, Barrett-Connor E, Zhang C, Eaton CB, May HT, Anderson JL, Sesso HD. Circulating 25-hydroxy-vitamin D and risk of cardiovascular disease: a meta-analysis of prospective studies. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):819-29. doi: 10.1161/CIRCOUTCOMES.112.967604. Epub 2012 Nov 13. Review. — View Citation

* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lipid profile	Total cholesterol, LDL cholesterol , HDL cholesterol, non HDL cholesterol, Triglycerides	2 years
Secondary	C-reactive protein		2 years
Secondary	Body Weight		2 years
Secondary	Blood Pressure		2 years
Secondary	serum calcium		2 years
Secondary	serum phosphore		2 years
Secondary	serum PTH		2 years
Secondary	serum creatinine		2 years
Secondary	serum albumin		2 years

External 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.