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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Bambino Gesù Hospital and Research Institute
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT02098317
First received: March 24, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
NAFLD
Non Alcoholic Steatohepatitis (NASH)
Drug: DHA plus Vitamin D
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD

Resource links provided by NLM:


Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • Improvement in NAFLD Activity Score (NAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    clinical examination, medical history and specific laboratory parameters


Estimated Enrollment: 66
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098317

Contacts
Contact: Valerio Nobili, Prof nobili66@yahoo.it

Locations
Italy
Bambino Gesù Children Hospital Recruiting
Rome, Italy, 00165
Contact: Valerio Nobili, Professor       nobili66@yahoo.it   
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Valerio Nobili, Professor Bambino Gesù Children Hospital
  More Information

No publications provided

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
Study First Received: March 24, 2014
Last Updated: March 26, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014