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DHA and Vitamin D in Children With Biopsy-proven NAFLD (VitD_DHA)

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ClinicalTrials.gov Identifier: NCT02098317
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
NAFLD Non Alcoholic Steatohepatitis (NASH) Drug: DHA plus Vitamin D Drug: Placebo Phase 3

Detailed Description:

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 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
Drug: DHA plus Vitamin D
DHA 500 mg plus Vitamin D 800 IU

Placebo Comparator: 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
Drug: Placebo
Placebo pearls mimicking pearls with DHA and Vitamin D




Primary Outcome Measures :
  1. Improvement in NAFLD Activity Score (NAS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile [ Time Frame: at 6 and 12 months ]
  2. safety [ Time Frame: 6 months ]
    clinical examination, medical history and specific laboratory parameters



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098317


Locations
Italy
Bambino Gesù Children Hospital
Rome, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Valerio Nobili, Professor Bambino Gesù Children Hospital

Responsible Party: Valerio Nobili, Professor, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02098317     History of Changes
Other Study ID Numbers: VD3_DHA_NAFLD
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Valerio Nobili, Bambino Gesù Hospital and Research Institute:
NAFLD
NASH
DHA
VITAMIN D
OBESITY
CHILDREN

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents