Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2 (VITAD/2)
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|ClinicalTrials.gov Identifier: NCT03810261|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Dietary Supplement: Oil-based vitamin D Dietary Supplement: Water-based vitamin D Dietary Supplement: Vitamin D capsules||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Oil-based vitamin D group
Oil-based vitamin D, 1000 IU/day for 8 weeks
Dietary Supplement: Oil-based vitamin D
Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.
Experimental: Water-based vitamin D group
Water-based 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.
Experimental: Vitamin D capsules group
Vitamin D capsules with starch-adsorbed vitamin D (powder), 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.
No Intervention: Control group
This group will receive no intervention.
- Change in vitamin D serum concentration after 8 weeks of supplementation [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810261
|Contact: Katja Žmitek, PhDemail@example.com|
|Contact: Igor Pravst, PhDfirstname.lastname@example.org|
|Nutrition Institute, Ljubljana||Recruiting|
|Ljubljana, Slovenia, 1000|
|Contact: Katja Žmitek +386 1 283 1700 email@example.com|
|Contact: Igor Pravst, PhD +386 590 68870 firstname.lastname@example.org|
|Principal Investigator: Katja Žmitek, PhD|
|Principal Investigator:||Katja Žmitek, PhD||Researcher|