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

NCT ID: NCT06176157

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Vitamin D Deficiency

Keywords

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Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral vitamin D2 group

Group Type ACTIVE_COMPARATOR

vitamin D2, vitamin D3

Intervention Type DIETARY_SUPPLEMENT

comparing parentral D2, D3, to oral D2, D3

oral vitamin D3 group

Group Type ACTIVE_COMPARATOR

vitamin D2, vitamin D3

Intervention Type DIETARY_SUPPLEMENT

comparing parentral D2, D3, to oral D2, D3

Parenteral vitamin D2 group

Group Type ACTIVE_COMPARATOR

vitamin D2, vitamin D3

Intervention Type DIETARY_SUPPLEMENT

comparing parentral D2, D3, to oral D2, D3

Parenteral vitamin D3 group

Group Type ACTIVE_COMPARATOR

vitamin D2, vitamin D3

Intervention Type DIETARY_SUPPLEMENT

comparing parentral D2, D3, to oral D2, D3

Interventions

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vitamin D2, vitamin D3

comparing parentral D2, D3, to oral D2, D3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Magdy Hassan Nawar

Lecturer of Pediatric Endocrinology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa M Nawar, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Central Contacts

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Marwa M Nawar, Lecturer

Role: CONTACT

Phone: +201005368647

Email: [email protected]

Heba H ELsedfy, professor

Role: CONTACT

Phone: +201005189166

Email: [email protected]

Other Identifiers

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FMASU MS468/2023

Identifier Type: -

Identifier Source: org_study_id