NCT05980026

Brief Summary

The investigators conducted this randomized-controlled trial to assess the effect of oral omega-3 supplementation on glycemic control, lipid profile, albuminuria level, kidney injury molecule-1 (KIM-1) and carotid intima media thickness (CIMT) to participants who were pediatric patients with T1DM and diabetic nephropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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 10, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

July 28, 2023

Last Update Submit

August 4, 2023

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • change in UACR (mg/g creatinine) level

    Urinary albumin excretion rate(mg/g creatinine)

    6 months

Secondary Outcomes (2)

  • change in KIM-1 level (ng/mL)

    6 months

  • change in HbA1c(%)

    6 months

Study Arms (2)

oral omega-3 fatty acids supplementation

ACTIVE COMPARATOR

Intervention group included pediatric patients with diabetic nephropathy receiving oral omega-3 fatty acids supplementation on a daily basis.

Drug: oral omega-3 fatty acids supplementation

Placebo comparator

PLACEBO COMPARATOR

Placebo group or control patients received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.

Dietary Supplement: Placebo

Interventions

oral omega-3 fatty acids supplementationDRUG

oral omega-3 fatty acids supplementation

oral omega-3 fatty acids supplementation
PlaceboDIETARY_SUPPLEMENT

Patients in placebo group received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.

Placebo comparator

Eligibility Criteria

Age12 Years - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with T1DM on regular insulin therapy.
  • age from 12 to 18 years.
  • disease duration at least 5 years.
  • having diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion \[UAE\] 30-299 mg/g creatinine).
  • hemoglobin A1c (HbA1c) ≤8.5% (69 mmol/mol).
  • persistent microalbuminuria was confirmed by abnormal two or three urine samples over a 3- to 6-months period prior to the study despite angiotensin converting enzyme inhibitors (ACE-Is)

You may not qualify if:

  • patients with any clinical evidence of infection.
  • patients with renal impairment due to causes other than diabetes.
  • other diabetic complications than nephropathy.
  • elevated liver enzymes.
  • hyper- or hypo-thyroidism.
  • intake of any vitamins or food supplements one month before study.
  • participation in a previous investigational drug study within the three months preceding screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy Elbarbary

Cairo, 11361, Egypt

Location

Related Publications (1)

  • Elbarbary NS, Ismail EAR, Mohamed SA. Omega-3 fatty acids supplementation improves early-stage diabetic nephropathy and subclinical atherosclerosis in pediatric patients with type 1 diabetes: A randomized controlled trial. Clin Nutr. 2023 Dec;42(12):2372-2380. doi: 10.1016/j.clnu.2023.10.007. Epub 2023 Oct 13.

    PMID: 37862823DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of Pediatrics

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

January 10, 2022

Primary Completion

December 17, 2022

Study Completion

January 14, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

EG(1)