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Not yet recruitingNCT06176157Updated Dec 19, 2023

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

A Phase 4 interventional study of vitamin D2, vitamin D3 in Vitamin D Deficiency, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
01

Study 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

02

Conditions studied

  • Vitamin D Deficiency

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Keywords

  • Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral
03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's planned enrollment of 120 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    oral vitamin D2 group

    Dietary Supplement: vitamin D2, vitamin D3

  • Active comparator
    oral vitamin D3 group

    Dietary Supplement: vitamin D2, vitamin D3

  • Active comparator
    Parenteral vitamin D2 group

    Dietary Supplement: vitamin D2, vitamin D3

  • Active comparator
    Parenteral vitamin D3 group

    Dietary Supplement: vitamin D2, vitamin D3

Interventions

  • Dietary supplementvitamin D2, vitamin D3

    comparing parentral D2, D3, to oral D2, D3

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — After Publishing the research individual data will be available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06176157
Lead sponsor
Ain Shams University
Responsible party
Marwa Magdy Hassan Nawar (Lecturer of Pediatric Endocrinology, Faculty of Medicine, Ain Shams University) — Principal investigator
First posted
Dec 19, 2023
Start date
Dec 2023 (estimated)
Primary completion
Mar 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Dec 19, 2023

Study contacts

Marwa M Nawar, Lecturer
Contact
marwa_magdy@med.asu.edu.eg
+201005368647
Heba H ELsedfy, professor
Contact
hebased@yahoo.com
+201005189166
Marwa M Nawar, Lecturer
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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