NCT06176157

Brief Summary

A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

December 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 9, 2023

Last Update Submit

December 9, 2023

Conditions

Vitamin D Deficiency

Keywords

Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral

Outcome Measures

Primary Outcomes (1)

  • serum 25(OH) D level after 1,2,3 months of supplementation

    3 months

Study Arms (4)

oral vitamin D2 group

ACTIVE COMPARATOR
Dietary Supplement: vitamin D2, vitamin D3

oral vitamin D3 group

ACTIVE COMPARATOR
Dietary Supplement: vitamin D2, vitamin D3

Parenteral vitamin D2 group

ACTIVE COMPARATOR
Dietary Supplement: vitamin D2, vitamin D3

Parenteral vitamin D3 group

ACTIVE COMPARATOR
Dietary Supplement: vitamin D2, vitamin D3

Interventions

vitamin D2, vitamin D3DIETARY_SUPPLEMENT

comparing parentral D2, D3, to oral D2, D3

Parenteral vitamin D2 groupParenteral vitamin D3 grouporal vitamin D2 grouporal vitamin D3 group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • laboratory evidence of vitamin D deficiency or insufficiency without clinical signs of rickets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

ErgocalciferolsCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Marwa M Nawar, Lecturer

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa M Nawar, Lecturer

CONTACT

+201005368647marwa_magdy@med.asu.edu.eg

Heba H ELsedfy, professor

CONTACT

+201005189166hebased@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric Endocrinology, Faculty of Medicine

Study Record Dates

First Submitted

December 9, 2023

First Posted

December 19, 2023

Study Start

December 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

December 19, 2023

Record last verified: 2023-12