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Efficacy of High versus Conventional Dose of Ergocalciferol Supplementation on Serum 25-Hydroxyvitamin D and Interleukin-6 levels in Hemodialysis Patients with Vitamin D Deficiency: Multicenter, Randomized, Controlled Study

Efficacy of High versus Conventional Dose of Ergocalciferol Supplementation on Serum 25-Hydroxyvitamin D and Interleukin-6 levels in Hemodialysis Patients with Vitamin D Deficiency: Multicenter, Randomized, Controlled Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200213006
Enrollment
Unknown
Registered
2020-02-13
Start date
2017-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

End stage renal disease&#44

Interventions

For treatment with high&#45
dose group&#44
the patients were received the double dose of ergocalciferol of the conventional group. (For patients with serum 25[OH]D levels between 20&#45
29.9 ng/mL&#44
ergocalciferol was given orally at 100&#44
000 units per month for two months whereas for serum 25[OH]D levels less than 20 ng/mL&#44
ergocalciferol was given at 100&#44
000 units weekly for two months).,For patients with serum 25[OH]D levels between 20&#45
ergocalciferol was given orally at 50&#44
000 units per month for two months whereas for serum 25(OH)D levels less than 20 ng/mL&#44
ergocalciferol was given at 50&#44
000 units weekly for two months.
Active Comparator Drug,Active Comparator Drug
High&#45
dose group,Conventional dose group

Sponsors

Phramongkutklao Hospital and College of Medicine, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria included all ESRD patients undergoing hemodialysis from five dialysis units in Bangkok and Nonthaburi Province, Thailand, aged more than eighteen years with a dialysis vintage of at least three months, serum 25[OH]D levels less than 30 ng/mL, corrected serum calcium less than 10.5 mg/dL, serum phosphate less than 4.5 mg/dL, serum albumin more than 3 g/dL and ability to provide informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria were acute medical illness or active infection within last month, malignancy, history of chronic inflammatory disease (e.g. autoimmune disease, inflammatory bowel disease), liver cirrhosis, pregnant, breast feeding, previous renal transplantation, use of any vitamin D compound, glucocorticoids, or immunosuppressants within three months before randomization, history of allergy to ergocalciferol, or elevated serum intact parathyroid hormone (iPTH) levels more than 500 pg/mL.

Design outcomes

Primary

MeasureTime frame
The efficacy of a given dose of ergocalciferol was the achievement of vitamin D sufficiency 8 weeks serum 25(OH)D levels—

Secondary

MeasureTime frame
mean changes of serum IL-6 concentrations, serum calcium and phosphorus levels 8 weeks serum IL-6 levels, serum calcium, serum phosphorus levels—

Countries

Thailand

Contacts

Public ContactWittaya Siricheepchaiyan
wolyawitya@hotmial.com081-6992411

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026