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Evaluating the effect of vitamin D3 supplementation on bone infection treatment and on sleep quality, anxiety and depression in patients with bone infection

Evaluating the effect of vitamin D3 supplementation on chronic osteomyelitis treatment and on sleep quality, anxiety and depression in patients with chronic osteomyelitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201609026026N4
Enrollment
50
Registered
2017-04-10
Start date
2016-09-28
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Chronic osteomyelitis. Staphylococcal infection, unspecified site

Interventions

Intervention 1: Intervention: Four vitamin D3 pearls (50000 IU) at baseline and two vitamin D3 pearls (50000 IU) after 1, 2, 3, 4, and 5 months. Intervention 2: Control: Four placebo pearls at baseli
Treatment - Drugs
Placebo
Intervention: Four vitamin D3 pearls (50000 IU) at baseline and two vitamin D3 pearls (50000 IU) after 1, 2, 3, 4, and 5 months
Control: Four placebo pearls at baseline and two placebo pearls after 1, 2, 3, 4, and 5 months

Sponsors

Kerman Univesity of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with chronic osteomyelitis in the 16-55 age range Exclusion criteria: use of other vitamin D supplements; use of immunosuppressants; history of hypercalcemia or nephrolithiasis; sarcoidosis; kidney disorders requiring dialysis or polycystic kidney disease; cirrhosis; cancer; baseline plasma calcium (corrected for plasma albumin concentration) greater than 10.4 mg/dL or less than 8.4 mg/dL

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ESR. Timepoint: At baseline, after 2 weeks and after 1, 2,3,4, 5 and 6 months. Method of measurement: Blood test.;CRP. Timepoint: At baseline, after 2 weeks and after 1, 2,3,4, 5 and 6 months. Method of measurement: Blood test.;Clinical presentations. Timepoint: At baseline, after 2 weeks and after 1, 2,3,4, 5 and 6 months. Method of measurement: Physical examination.

Secondary

MeasureTime frame
Mental disorders. Timepoint: At baseline, after 3 and 6 months. Method of measurement: Questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Dabaghzadeh

Kerman University of Medical Sciences

fatemeh_dabaghzadeh@yahoo.com+98 34 3132 5212

Outcome results

None listed

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