Conditions: Vitamin D Deficiency
Keywords: vitamin D insufficiency Cholecalciferol D3 Parathyroid Hormone 25-hydroxyvitamin D3 RDA, recommended daily intake (nutrition policy) Vitamin D Hypovitaminosis-D Pharmacologic treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.

Detailed description:
The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.

Arms:
arm 1: Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L arm 2: Vitamin D3 2000 IU daily, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 nmol/l will be randomised to arm 3: Vitamin D3 2000 IU weekly, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 mol/l will be randomised to arm 4: Vitamin D3, 2000 IU daily i.e. 3 drops orally once daily for 12 weeks, treatment to patients with Serum-vitamin D levels between 50 and 74 nmol/L

Interventions: intervention 1: Cholecalciferol high dose at Vitamin D deficiency intervention 2: Cholecalciferol median dose at Vitamin D insufficiency intervention 3: Cholecalciferol low dose at Vitamin D deficiency intervention 4: Cholecalciferol median dose at sufficient Vitamin D level
Intervention descriptions: intervention 1: 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks intervention 2: 2000 IU daily i.e. 3 drops orally once a day for 12 weeks, intervention 3: 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, intervention 4: 2000 IU daily i.e. 3 drops orally once daily for 12 weeks

Protocol document: