The Effect of Vitamin D Supplementation on Psoriasis Severity

NCT03334136 | Completed

• 3 other identifiers: TromsøPsoriasis-2016-12016-003378-422016/1789
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effect of oral vitamin D supplementation on the severity of psoriasis measured by Psoriasis Area Severity Index (PASI) in adults with lower vitamin D levels. Half of the participants will receive vitamin D, while the other half receive placebo.

Conditions

Psoriasis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area Severity Index (PASI) score

  The difference in change between the vitamin D and placebo group in psoriasis severity measured by PASI score. Score range from 0-72, where a higher value indicates a more severe disease.

  Baseline and 4 months

Secondary Outcomes (17)

• Physician Global Assessment (PGA) score

  Baseline and 4 months

• Dermatology Quality of Life Index (DLQI) score

  Baseline, 8 weeks and 4 months

• Self-administered psoriasis area and severity index (SAPASI) score

  Baseline, 8 weeks and 4 months

• Use of psoriasis related medication: topical treatment I

  Baseline and 4 months

• Use of psoriasis related medication: topical treatment II

  Baseline, 8 weeks and 4 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

25-hydroxyvitamin D 20.000 IU capsule given orally. Five capsules the first day and thereafter one capsule every week for 4 months.

Drug: 25-Hydroxyvitamin D

Placebo

PLACEBO COMPARATOR

Placebo oral capsules. Five capsules the first day and thereafter one capsule every week for 4 months.

Drug: Placebo oral capsule

Interventions

25-Hydroxyvitamin D DRUG

Capsules containing 20 000 IU 25-hydroxyvitamin D given orally: five capsules the first day and thereafter one capsule every week for 4 months (average daily dose approximately 3.000 IU)

Also known as: Dekristol

Vitamin D

Placebo oral capsule DRUG

Five capsules the first day and thereafter one capsule every week for 4 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plaque psoriasis diagnosis confirmed by a dermatologist at visit 1.
• Serum 25 hydroxyvitamin D levels \< 60 nmol/L confirmed at visit 1

You may not qualify if:

• age above 79 years
• subjects allergic to nuts (the study capsules contain peanut oil)
• subjects with primary hyperparathyroidism
• granulomatous diseases (sarcoidosis, tuberculosis, granulomatosis with polyangiitis (Wegners))
• reduced kidney function (creatinine \> 130 μmol/L in males and 120 μmol/L in females)
• measured systolic blood pressure (BP) \> 174 mmHg, diastolic BP \> 104 mmHg
• poorly controlled diabetes (HbA1c \> 9.0 %)
• renal stones the last five years
• subjects who use solarium on a regular basis (more than twice a month on average), nor can this be performed under the course of the study
• subjects who plan holiday(s) in tropical areas including the Canary Islands for more than two weeks under the course of the study
• subjects with clinical signs of proximal myopathy (problems with standing up from chair or walking stairs)
• subjects seriously physically or mentally ill and unfit for participation in a clinical study (as judged by one of the study doctors)
• subjects who have been diagnosed with or treated for organ cancer within the past 12 months (basal cell carcinoma and other limited nonmelanoma skin cancer or melanoma in situ can be included).
• subjects using vitamin D supplementation (incl. cod liver oil) above 800 IU (20 microgram) (5 ml codliver oil = 400 IU) or active vitamin D drugs (Rocaltrol or Etalpha) within the last month before study start are excluded. Furthermore, vitamin D supplements (e.g. codliver oil) or drugs apart from the study medication can not be used during the course of the study.
• subjects who have started treatment with a new oral or injection drug for psoriasis or psoriasis arthritis (E.g. Methotrexate, Cyclosporine, Acitretin or biological treatment like Humira, Remicade, Stelara and others ) within the last 2 months (evaluated by dermatologist). Nor can a new oral or injection drug which influences psoriasis severity be introduced during the study. In this case the participant will be withdrawn from the study.

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Royal Norwegian Ministry of Health: collaborator
• University of Tromso: collaborator
• Cornell University: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

• Jenssen M, Furberg AS, Jorde R, Wilsgaard T, Danielsen K. Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial. JAMA Dermatol. 2023 May 1;159(5):518-525. doi: 10.1001/jamadermatol.2023.0357.

  PMID: 36988936 DERIVED

MeSH Terms

Conditions

Psoriasis; Vitamin D Deficiency

Interventions

25-hydroxyvitamin D

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Kjersti Danielsen, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for 4 months.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: November 7, 2017
• Study Start: November 24, 2017
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

NO (1)