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

Ain Shams University

Status and phase: Not yet enrolling; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: vitamin D2, vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT06176157

FMASU MS468/2023

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

oral vitamin D2 group

Active Comparator group

Treatment:

Dietary Supplement: vitamin D2, vitamin D3

oral vitamin D3 group

Active Comparator group

Treatment:

Dietary Supplement: vitamin D2, vitamin D3

Parenteral vitamin D2 group

Active Comparator group

Treatment:

Dietary Supplement: vitamin D2, vitamin D3

Parenteral vitamin D3 group

Active Comparator group

Treatment:

Dietary Supplement: vitamin D2, vitamin D3