DHA and Vitamin D in Children With Biopsy-proven NAFLD (VitD_DHA)
Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression.
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (NAFLD).
調査の概要
詳細な説明
Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical placebo (n=33) given orally for a period of 6 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.
Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Rome、イタリア、00165
- Bambino Gesu Children Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- biopsy consistent with the diagnosis of NAFLD/NASH
- reduced serum levels of vitamin D aminotransferases (ALT) levels <10 upper limit of normal
- hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- International normalized ratio (INR) < 1,3
- Albumin > 3 g/dl
- total bilirubin < 2,5 mg/dl
- no previous gastrointestinal bleeding
- no previous portosystemic encephalopathy
- normal renal function
- no hepatitis B, hepatitis C infection
- normal cell blood count
Exclusion Criteria:
- alcohol consumption
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease
- every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- finding of active liver disease due to other causes
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：TREATED GROUP
this group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks
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DHA 500 mg plus Vitamin D 800 IU
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プラセボコンパレーター：PLACEBO GROUP
this group will treated with identical placebo pearls given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks
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Placebo pearls mimicking pearls with DHA and Vitamin D
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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 |
時間枠 |
|---|---|
|
NAFLD活動スコア（NAS）の改善
時間枠：12ヶ月
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12ヶ月
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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 |
|---|---|---|
|
improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
時間枠：at 6 and 12 months
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at 6 and 12 months
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|
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safety
時間枠：6 months
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clinical examination, medical history and specific laboratory parameters
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6 months
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協力者と研究者
捜査官
- 主任研究者：Valerio Nobili, Professor、Bambino Gesu Children Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。