Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2

Summary

The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption.

A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65 years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in Part 1 of the study, after completion of winter sampling.

Study subjects will be randomised into four study groups (at least 18 subjects per study group). Three different treatments will be compared with a control group, which will not receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C) Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are commercially available. Prior to study, actual level of vitamin D will be determined using appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two months, in all three groups. Second serum vitamin D level will be determined on last day of the treatment, and compared with pre-treatment vitamin D level.

Conditions

• Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Oil-based vitamin D

Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.

DIETARY_SUPPLEMENT

Water-based vitamin D

Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.

DIETARY_SUPPLEMENT

Vitamin D capsules

Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences

  collaborator OTHER

• Slovenian Research Agency

  collaborator OTHER

• Valens Int. d.o.o., Slovenija

  collaborator INDUSTRY

• Institute of Nutrition, Slovenia (Nutris)

  lead OTHER

Principal Investigators

• Katja Žmitek, PhD · Researcher

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-08

Primary Completion

2019-04-02

Completion

2019-04-02

Countries

• Slovenia

Study Locations