Vitamin D, Cardiovascular Disease, and African Americans

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

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HaliImekamilika

Wadhamini

Washington University School of Medicine

Washirika

American Diabetes Association

JARIBIO LA KLINIKI: NCT01655810

BioSeek: nct01655810

Maneno muhimu

Kikemikali

African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.

Maelezo

This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.

Tarehe

Imethibitishwa Mwisho:	05/31/2020
Iliyowasilishwa Kwanza:	07/18/2012
Uandikishaji uliokadiriwa Uliwasilishwa:	07/31/2012
Iliyotumwa Kwanza:	08/01/2012
Sasisho la Mwisho Liliwasilishwa:	06/02/2020
Sasisho la Mwisho Lilichapishwa:	06/04/2020
Tarehe halisi ya kuanza kwa masomo:	08/12/2012
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	02/08/2018
Tarehe ya Kukamilisha Utafiti:	02/08/2018

Hali au ugonjwa

Vitamin D Deficiency

Type 2 Diabetes Mellitus

Cardiovascular Disease

Uingiliaji / matibabu

Dietary Supplement: Vitamin D 4000 IU

Dietary Supplement: Vitamin D 600 IU

Dietary Supplement: Calcium carbonate

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Active Comparator: Vitamin D 4000 IU PO daily	Dietary Supplement: Vitamin D 4000 IU Multivitamin containing cholecalciferol 4000 units orally daily
Active Comparator: Vitamin D 600 IU PO daily	Dietary Supplement: Vitamin D 600 IU Multivitamin containing cholecalciferol 600 units orally daily

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	50 Years Kwa 50 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - African Americans of both genders - Age 50-70 years - Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination - 25(OH)D level < 20 ng/ml - BP < 140/90 mmHg; LDL < 140 mg/dl Exclusion Criteria: - Pregnancy - Cardiovascular disease - Stage 3 or worse chronic kidney disease - High urine or serum calcium or history of recurrent kidney stones - Unstable medical conditions or major systemic diseases such as malignancy

Matokeo

Hatua za Matokeo ya Msingi

1. Change from baseline in carotid intima-medial thickness [0, 6, and 12 months]

Hatua za Matokeo ya Sekondari

1. Change from baseline in systemic inflammatory markers [0, 6, and 12 months]

2. Serum calcium [0, 1, 3, 6, 9, and 12 months]

3. Urinary Calcium [0, 1, 3, 6, 9, and 12 months]