NCT03810261

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Institute of Nutrition, Slovenia (Nutris) · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-01-08
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2019-01-18
• Last updated: 2021-06-22

Locations

1 site across 1 country: Slovenia