Skip to main content
OpenTrials
Completed

NCT Number: NCT03920150

Vitamin D 24'000 IU for Oral Intermittent Supplementation

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values >75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pharmaceutical Care Research Group

Basel, 4056, Switzerland

About this study

Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.

All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • vitamin D deficiency by serum level <50 nmol/l

Exclusion criteria

  • hypercalcaemia

Treatment and study plan

Vitamin D3

Drug

Patient will be treated with 3 doses of alcoholic solution for 3 months.

Other names: Vi-De 3 Monatsdosis

Vitamin D oily capsules

Drug

Patient will be treated with 3 capsules for 3 months.

Primary outcomes

  1. Serum level of vitamin D

    Time frame: 3 months of treatment

    Level of serum vitamin D after 3 month treatment compared to baseline value

Secondary outcomes

  1. Serum level of vitamin D after loading dose

    Time frame: up to 4 months of treatment

    Level of serum vitamin D > 75 nmol/l after an individual number of treatment weeks, calculated with a loading dose formula.

  2. Adverse Drug Reactions

    Time frame: 3 months of treatment

    Number and severity of adverse drug reactions during treatment

  3. Adherence to medication

    Time frame: 3 months of treatment

    Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: DO-IT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.