NCT04584905

Brief Summary

Primary outcome is assessment of nutritional status of children with CKD. Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 23, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

September 23, 2020

Last Update Submit

May 31, 2021

Conditions

Nutrition Disorders, Child

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Assessment of nutritional status of children with CKD.

    by measuring body mass index in kg/m2.

    from January 2021 to June 2021

Secondary Outcomes (1)

  • Assess STAMP screening tool

    from January 2021 to June 2021

Interventions

dietary supplements for CKD patientsDIETARY_SUPPLEMENT

follow up and assessment of nutritional status of CKD patients

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children of both sexes. Diagnosed as chronic kidney disease. Age: 2 years up to 15 Years Children

You may qualify if:

  • Children of both sexes.
  • Diagnosed as chronic kidney disease.
  • Age: 2 years up to 15 Years Children.

You may not qualify if:

  • Age: less than 2 years old child and more than 15 years old child.
  • Previously diagnosed to have any co- morbid or systemic disease other than CKD.
  • Irregular dialysis.
  • Renal transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Universty Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Child Nutrition DisordersRenal Insufficiency, Chronic

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

maram mohamed amir, resident doctor

CONTACT

01014808876Maramamior1994@yahoo.com

mohamed A AbdelMoez, prof

CONTACT

01005208016abdellatefabdelmoez@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 14, 2020

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)