NCT06268184

Brief Summary

evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

January 29, 2024

Last Update Submit

July 16, 2024

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (16)

  • decrease oxidative stress

    measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)

    6 months

  • increase antioxidant activity

    measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)

    6 months

  • improvement of nutritional status assessed by anthropometric measurements.

    including weight measure in kilograms ,height in meters, BMI calculated by division of weight on (height in meters)2

    6 months

  • mid upper arm circumference in centimeters

    improvement of nutritional status assessed by anthropometric measurements.

    6 months

  • triceps skin fold thickness in millimeter's

    improvement of nutritional status assessed by anthropometric measurements.

    6 months

  • improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    including fat mass index ( FMI)

    6 months

  • improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    fat free mass index (FFMI)

    6 months

  • improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    total body water percentage (TBW%)

    6 months

  • improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    Basal metaboic rate (BMR)

    6 months

  • improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    muscle mass percentage (MM%)

    6 months

  • improvement of nutritional status assessed by laboratory investigations.

    serum albumin level

    6 months

  • s. ionized calcium level

    6 months

  • s.phosphorus level

    6 months

  • alkaline phosphatase level

    6 months

  • parathormone hormone level

    6 months

  • 25(oh)vitamin D level

    improvement of nutritional status assessed by laboratory investigations.

    6 months

Study Arms (2)

omega 3

ACTIVE COMPARATOR

D3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months

Dietary Supplement: D3 LAB SYRUP

placebo

PLACEBO COMPARATOR

Placebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives).

Dietary Supplement: placebo syrup

Interventions

D3 LAB SYRUPDIETARY_SUPPLEMENT

omega 3 suplementation

omega 3
placebo syrupDIETARY_SUPPLEMENT

placebo syrup contains purified water, glycerin, xanthan gum, tween 80, methyl paraben, propyl paraben, sorbitol solution70% and apple flavor.

placebo

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ESRD children and adolescents on regular hemodialysis for at least 3 months
  • Age ranging from 6 to18 years.

You may not qualify if:

  • Systematic disease other than CKD eg SLE
  • Severe active infection.
  • Allergies to any of the ingredients in omega-3 product used in this study (e.g. fish oil, bovine gelatin).
  • Omega-3 fatty acid or any other antioxidants consumption within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tanta, Gharbia Governorate, Egypt

RECRUITING

Central Study Contacts

noha sayed esmaeil, assistenet lecturer

CONTACT

01016919217noooooha1990@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 20, 2024

Study Start

October 4, 2021

Primary Completion

March 1, 2024

Study Completion

August 15, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)