Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3

December 9, 2023 updated by: Marwa Magdy Hassan Nawar, Ain Shams University

Vitamin D Supplementation in Vitamin D Deficient/Insufficient Children Oral or Parenteral! D2 or D3, A Randomized Controlled Trial.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Heba H ELsedfy, professor
  • Phone Number: +201005189166
  • Email: hebased@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • vitamin D or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oral vitamin D2 group
Dietary supplement: vitamin D2, vitamin D3
comparing parentral D2, D3, to oral D2, D3
Active Comparator: oral vitamin D3 group
Dietary supplement: vitamin D2, vitamin D3
comparing parentral D2, D3, to oral D2, D3
Active Comparator: Parenteral vitamin D2 group
Dietary supplement: vitamin D2, vitamin D3
comparing parentral D2, D3, to oral D2, D3
Active Comparator: Parenteral vitamin D3 group
Dietary supplement: vitamin D2, vitamin D3
comparing parentral D2, D3, to oral D2, D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum 25(OH) D level after 1,2,3 months of supplementation
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Marwa M Nawar, Lecturer, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS468/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After Publishing the research individual data will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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