Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002634203 Date of Approval: 19/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title vitamin D and non alcoholic fatty liver disease in children
Official scientific title effect of oral vitamin D supplementation in children with non alcoholic fatty liver disease
Brief summary describing the background and objectives of the trial background: vitamin D deficiency was found to be common in patients with non alcoholic fatty liver diseae(NAFLD)and was associated withy severity of histology in several studies.the relation between the occurence of NAFLD and vitamin D deficiency is established. the effect of supplementation of vitamin D on hepatic fat content have never been tested in pediatrics. Objectives:to assess the effect of vitamin D supplementation for 6 months on NAFLD pediatric patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied non alcoholic fatty liver disease,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised computer generated sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin D supplementation 2000 u/day 6 months oral treatment 50 Active-Treatment of Control Group
Control Group oral glucose 5% 2 droppe of glucose 5% 6 months 2 dropper with glucose 5% were taken daily for 6 months in children with NAFLD 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age less than 18 years, children with NAFLD with vitamin D deficiency age more than 18 years, other chronic liver disease, liver cirrhosis, autoimmune hepatitis, normal vitamin D level, renal failure, cancer, hyper/hypoparathyroidism, hypercalcemia,recent (previous 6 months) supplementation with vitamin D, and treatment with agents affecting calcium/vitamin D metabolism (anticonvulsants, glucocorticoids). 5 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/09/2017 local ethical committee of faculty of medicine, tanta university
Ethics Committee Address
Street address City Postal code Country
EL geish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in hepatic fat content, grading of NAFLD, and vitamin D level after 6 months of treatment
Secondary Outcome correlation between serum vitamin D level and various clinical, laboratory variables, and grading of NAFLD after 6 months of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital elgeish street tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital elgeish street tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital elgeish street tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Doaa El Amrousy El motasem street tanta 31511 Egypt
shaymaa El Rifaey elnahas street tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com 00201278155283 motasem street
City Postal code Country Position/Affiliation
tanta 31511 Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Public Enquiries mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 elgeish street
City Postal code Country Position/Affiliation
tanta 31511 Egypt manger of hospital
Role Name Email Phone Street address
Scientific Enquiries Nagat Elshmaa nagat_elshmaa@yahoo.com 00201279999697 elgalaa street
City Postal code Country Position/Affiliation
tanta 31511 Egypt associate professor of anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information