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).
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Rome, 이탈리아, 00165
- Bambino Gesu Children Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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NAFLD 활동 점수(NAS) 개선
기간: 12 개월
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12 개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
기간: at 6 and 12 months
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at 6 and 12 months
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safety
기간: 6 months
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clinical examination, medical history and specific laboratory parameters
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Valerio Nobili, Professor, Bambino Gesu Children Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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