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Safety study of a large dose of vitamin D administered to hemodialysis patients and assessment of its effects on the parameters of bone abnormalities

Monthly administration of high-dose vitamin D3 in hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10043222
Enrollment
48
Registered
2022-02-18
Start date
2020-03-01
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovitaminosis D and secondary hyperparathyroidism Nutritional, Metabolic, Endocrine Vitamin D deficiency, Secondary hyperparathyroidism, not elsewhere classified

Interventions

Hemodialysis patients with secondary hyperparathyroidism and not on either active VD3 nor calcimimetics are included in the study to receive a large oral dose of vitamin D3 (300,000 units) every month

Sponsors

University of Sharjah
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Hemodialysis patients 2. On dialysis for more than 1 year 3. Not on active Vitamin D 4. Not on calcimimetics

Exclusion criteria

Exclusion criteria: 1. Tertiary hyperparathyroidism 2. Ongoing debilitating condition (e.g. cancer)

Design outcomes

Primary

MeasureTime frame
Measured at 0, 3, 6 and 9 months: 1. Serum levels of 25(OH)VD measured using the LIAISON® 25 OH Vitamin D assay 2. Serum levels of 1,25(OH)2 VD measured using the LIAISON® XL 1,25 Dihydroxyvitamin D assay 3. Serum levels of iPTH measured using the Atellica IM PTH assay

Secondary

MeasureTime frame
Measured at 0, 3, 6 and 9 months: 1. Serum calcium measured using the Atellica® CH Calcium (Ca) assay 2. Serum phosphorus measured using the Atellica™ CH Inorganic Phosphorus (IP) assay 3. Serum alkaline phosphatase measured using the Atellica™ CH Alkaline Phosphatase, concentrated (ALP_2c) assay

Countries

United Arab Emirates

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026