NCT03850886

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of Niacinamide supplementation on clinical outcome of fatty liver patients having type II DM through measurement of the following before and after Niacinamide administration: Liver enzymes, Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of life of patients before and after Niacinamide administration using Chronic Liver Disease questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 30, 2019

Last Update Submit

January 18, 2020

Conditions

Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Steatosis using Fibroscan with CAP

    using Fibroscan with CAP

    3 months

  • Adiponectin mesurement

    Endothelial dysfunction

    3 months

Secondary Outcomes (4)

  • Malondialdehyde

    3 monthes

  • HOMA-IR

    3 months

  • ALT, AST

    3 months

  • LDL, cholesterol

    3 months

Other Outcomes (1)

  • Chronic Liver Disease Questionnaire

    3 months

Study Arms (2)

Niacinamide group

EXPERIMENTAL

Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea

Dietary Supplement: Niacinamide Oral TabletDrug: Antidiabetic

Control group

ACTIVE COMPARATOR

diabetes management including metformin or Sulphonylurea

Drug: Antidiabetic

Interventions

Niacinamide Oral TabletDIETARY_SUPPLEMENT

Nature's Life Niacinamide 1000 mg

Also known as: Nicotinamide, Vitamin B3
Niacinamide group
AntidiabeticDRUG

Metformin or Sulphonylurea

Control groupNiacinamide group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male or female outpatients age 18 to 70 years old. 2. The diagnosis of NAFLD will be established according to the appearance of fatty liver on US or elevated liver enzymes (\>1.5 times normal level).

You may not qualify if:

  • \. History of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day in women).
  • \. Cirrhotic patients.
  • Fibroscan result \> 12Kpa or as
  • predicted from FIB 4 score \> 3.25
  • FIB-4 = age (yr) \* AST (IU/L)/platelet count (109/L) \* ALT1/2 (IU/L) 3. Hyper / hypoparathyroidism. 4. Cancer. 5. Viral hepatitis. 6. Biliary disease. 7. Autoimmune hepatitis 8. Other causes of liver disease (hemochromatosis, Wilson's disease). 9. Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (NSAIDs, Amiodarone and methotrexate) within 6 months before the start of the study and during the study.
  • \. Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them.
  • \. Pregnancy and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlZahraa hospital

Cairo, 02, Egypt

Location

Related Publications (1)

  • El-Kady RR, Ali AK, El Wakeel LM, Sabri NA, Shawki MA. Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial. Ther Adv Chronic Dis. 2022 Feb 23;13:20406223221077958. doi: 10.1177/20406223221077958. eCollection 2022.

    PMID: 35222903DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

NiacinamideHypoglycemic Agents

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assisstant at department clinical pharmacy

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 22, 2019

Study Start

January 15, 2019

Primary Completion

August 7, 2019

Study Completion

August 7, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

EG(1)