Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents
2016年3月30日 更新者：Seema Kumar、Mayo Clinic
Vitamin D deficiency has been linked to endothelial dysfunction in adults.
Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction.
Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.
調査の概要
詳細な説明
Subjects had a brief screening visit with one of the study team members. Past medical history, current medications and a brief dietary history was taken. The dietary history was taken to assess calcium intake in a day and was obtained via the validated Short Calcium questionnaire. Blood pressure, heart rate as well as height,weight, waist and hip circumference measurement was obtained by study staff. In addition, a brief physical examination to determine Tanner stage was also completed. This involved examination of both breasts and genitalia for adolescent female and only genitalia in males. A physical activity questionnaire (IPAQ) was also administered by the study staff at this visit. A blood draw of 5 ml to measure plasma 25(OH) D, calcium, phosphorus was obtained as part of the screening visit. For girls who had started menstruating, a urine pregnancy test was also obtained.
After the screening visit eligible subjects had baseline biochemical tests and an endothelial function assessment. Study participants received a pill container with six total pills of vitamin cholecalciferol (D3) (1 pill = 50,000 IU), with directions to take two pills once a month (100,000 IU) at the same time for a period of 3 months. Compliance was assessed at the 3 month visit by counting the number of pills remaining in the container.
At 1 month, the subjects had tests for serum calcium and 25 hydroxy vitamin D levels. A urine test for random calcium to creatinine ratio was also obtained.
At 2 months, the serum calcium, 25 hydroxy vitamin D levels, and calcium to creatinine ratio tests were repeated.
At the end of 3 months, biochemical tests and an endothelial function assessment were repeated. Medical history, questionnaires, and the physical exam were also repeated.
研究の種類
介入
入学 (実際)
19
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～18年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age 12-18 years
- BMI >95% for age and gender
- 25 (OH) D levels less than 30 ng/ml
Exclusion Criteria:
- 25 (OH) D levels >30 ng/mL
- Serum calcium >10.4 mg/dL
- Serum phosphorus > 4.7 mg/dl
- Pregnancy or nursing
- Current cancer
- Patients on vitamin D3 supplementation exceeding 400 IU/day
- Hypertension defined as Blood Pressure over the 95th percentile for age, gender and height
- Dietary calcium intake exceeding 1500 mg/day
- Hepatic or renal disorders
- Type 1 or type 2 diabetes mellitus
- Subjects receiving insulin, metformin, or oral hypoglycemic medications
- Subjects with malabsorption disorders (celiac disease, cystic fibrosis, inflammatory bowel disease)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Vitamin D3
Vitamin D3 supplementation at 100,000 IU once a month for 3 months
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Vitamin D 3 at 100,000 IU once a month for 3 months
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Flow Mediated Dilatation (FMD)
時間枠：baseline, 3 months
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Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery.
FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.
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baseline, 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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25-hydroxy Vitamin D (25[OH]D) Levels
時間枠：baseline, 3 months
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25(OH)D was measured using liquid chromatography-tandem mass spectrometry.
Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D_2 and 25(OH)D_3.
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baseline, 3 months
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Total Cholesterol
時間枠：baseline, 3 months
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Total cholesterol levels were measured by an enzymatic colorimetric assay.
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baseline, 3 months
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Triglycerides
時間枠：baseline, 3 months
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Total triglyceride levels were measured by an enzymatic colorimetric assay.
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baseline, 3 months
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Body Mass Index
時間枠：baseline, 3 months
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Body Mass Index (BMI) is a health index for comparing weight to height.
BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.
The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat.
A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy.
A body mass index in the range of 25 to 30 is regarded as overweight.
A body mass index over 30 is regarded as obese.
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baseline, 3 months
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International Physical Activity Questionnaire (IPAQ) Short Form Score
時間枠：baseline, 3 months
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The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day.
The score is reported in metabolic equivalent (MET)-minutes per week.
Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active).
The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week.
Therefore a score of > 3000 MET-minutes/week was possible.
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baseline, 3 months
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Calcium Intake Per Day
時間枠：baseline, 3 months
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Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ).
This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements.
The spreadsheet calculates the daily calcium intake (mg/day) from the data entered.
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baseline, 3 months
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Serum Parathyroid Hormone (PTH)
時間枠：baseline, 3 months
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A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood.
This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease.
PTH controls calcium and phosphorus levels in the blood.
PTH was measured by a two-site chemiluminescent immunometric assay.
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baseline, 3 months
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Fasting Glucose
時間枠：baseline, 3 months
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Plasma glucose was measured by hexokinase enzymatic assay.
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baseline, 3 months
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Fasting Insulin
時間枠：baseline, 3 months
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Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.
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baseline, 3 months
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Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)
時間枠：baseline, 3 months
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This calculation measures insulin resistance, and requires U.S. standard units.
The healthy range is 0.5 to 1.4.
Less than 1.0 means the subject is insulin-sensitive, which is optimal.
Above 1.9 indicates early insulin resistance.
Above 2.9 indicates significant insulin resistance.
The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5.
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baseline, 3 months
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High Sensitivity C-reactive Protein (Hs-CRP)
時間枠：baseline, 3 months
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A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD).
C-reactive protein (CRP) is a protein that increases in the blood with inflammation.
Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD.
The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD.
hs-CRP was measured using particle-enhanced immunonephelometry.
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baseline, 3 months
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Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels
時間枠：baseline, 3 months
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The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease.
A desirable level is <3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is >/= 4.14 mmol/L.
LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5.
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baseline, 3 months
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High Density Lipoprotein (HDL) Cholesterol Levels
時間枠：baseline, 3 months
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Total HDL cholesterol levels were measured by an enzymatic colorimetric assay.
The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease.
If a subject has a negative risk factor, a desirable HDL level would be >/= 1.55 mmol/L.
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baseline, 3 months
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Urine Calcium to Creatinine Ratio
時間枠：baseline, 3 months
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Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.
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baseline, 3 months
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Reactive Hyperemia Index (RHI)
時間枠：baseline, 3 months
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The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant's systolic blood pressure for a period of 5 min.
The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive.
Higher values are considered normal or improved endothelial function.
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baseline, 3 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年11月1日
一次修了 (実際)
2013年12月1日
研究の完了 (実際)
2013年12月1日
試験登録日
最初に提出
2012年11月16日
QC基準を満たした最初の提出物
2012年12月6日
最初の投稿 (見積もり)
2012年12月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年5月2日
QC基準を満たした最後の更新が送信されました
2016年3月30日
最終確認日
2016年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Vitamin D3の臨床試験
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Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, Denmark完了
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