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Vitamin D Supplementation on Cardiovascular Risk Factors

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
Florida International University

Maneno muhimu

Kikemikali

The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.

Maelezo

Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population.

Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke.

These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD.

Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.

Tarehe

Imethibitishwa Mwisho: 09/30/2017
Iliyowasilishwa Kwanza: 08/06/2011
Uandikishaji uliokadiriwa Uliwasilishwa: 08/07/2011
Iliyotumwa Kwanza: 08/08/2011
Sasisho la Mwisho Liliwasilishwa: 11/12/2017
Sasisho la Mwisho Lilichapishwa: 12/11/2017
Tarehe ya matokeo ya kwanza yaliyowasilishwa: 08/04/2017
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa: 11/12/2017
Tarehe ya matokeo ya kwanza kuchapishwa: 12/11/2017
Tarehe halisi ya kuanza kwa masomo: 06/30/2011
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 08/31/2013
Tarehe ya Kukamilisha Utafiti: 08/31/2013

Hali au ugonjwa

Type 2 Diabetes

Uingiliaji / matibabu

Drug: Cholecalciferol

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
Experimental: 4000 IU group
This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.
Experimental: 6000 IU group
This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 30 Years Kwa 30 Years
Jinsia Inastahiki KujifunzaAll
Hupokea Wajitolea wa AfyaNdio
Vigezo

Inclusion Criteria:

- Type 2 diabetes

- African American or Hispanic

- able to ambulate on their own

- aged between 30 - 70 years

Exclusion Criteria:

- Taking Supplemental Vitamin D

- Pregnant or Lactating women

- Receiving insulin therapy

- Not participating in other drug trials

- HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders

- Kidney failure or on dialysis

Matokeo

Hatua za Matokeo ya Msingi

1. Blood Lipid [Baseline]

Total cholesterol will be used as surrogate measures for cardiovascular disease risk.

Hatua za Matokeo ya Sekondari

1. Glycemic Control [Baseline]

hemoglobin A1C blood test

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