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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Oil-based vitamin D
Water-based vitamin D
Vitamin D capsules
Sponsored by
Nutrition Institute, Slovenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • vitamin D suboptimal status
  • Signed Informed consent form (ICF),
  • Caucasian race
  • Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
  • Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources
  • Willingness to follow all study procedures

Exclusion Criteria:

  • Pregnancy or breastfeeding,
  • Known or suspected allergy to any ingredient of the tested products in Part 2,
  • Pronounced avoidance of sunshine (eg reporting of allergy to the sun)
  • Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,
  • Special dietary habits used by a small part of the population (veganism, low-carb high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded)
  • Diets prescribed by the medical profession
  • Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases
  • Other diseases and conditions that affect the absorption and synthesis of vitamin D
  • Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium),
  • The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D,
  • Visiting the solarium in the last three months before joining the survey,
  • Mental incapacity that precludes adequate understanding or cooperation.

Sites / Locations

  • Nutrition Institute, Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Oil-based vitamin D group

Water-based vitamin D group

Vitamin D capsules group

Control group

Arm Description

Oil-based vitamin D, 1000 IU/day for 8 weeks

Water-based vitamin D, 1000 IU/day for 8 weeks

Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks

This group will receive no intervention.

Outcomes

Primary Outcome Measures

Change in vitamin D serum concentration after 8 weeks of supplementation

Secondary Outcome Measures

Full Information

First Posted
January 17, 2019
Last Updated
June 16, 2021
Sponsor
Nutrition Institute, Slovenia
Collaborators
VIST - Faculty of Applied Sciences, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
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1. Study Identification

Unique Protocol Identification Number
NCT03810261
Brief Title
Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
Acronym
VITAD/2
Official Title
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutrition Institute, Slovenia
Collaborators
VIST - Faculty of Applied Sciences, Slovenian Research Agency, Valens Int. d.o.o., Slovenija

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oil-based vitamin D group
Arm Type
Experimental
Arm Description
Oil-based vitamin D, 1000 IU/day for 8 weeks
Arm Title
Water-based vitamin D group
Arm Type
Experimental
Arm Description
Water-based vitamin D, 1000 IU/day for 8 weeks
Arm Title
Vitamin D capsules group
Arm Type
Experimental
Arm Description
Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will receive no intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oil-based vitamin D
Intervention Description
Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Water-based vitamin D
Intervention Description
Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D capsules
Intervention Description
Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.
Primary Outcome Measure Information:
Title
Change in vitamin D serum concentration after 8 weeks of supplementation
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: vitamin D suboptimal status Signed Informed consent form (ICF), Caucasian race Age between 18 and 65 years at the time of the signature of Informed consent form (ICF), Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources Willingness to follow all study procedures Exclusion Criteria: Pregnancy or breastfeeding, Known or suspected allergy to any ingredient of the tested products in Part 2, Pronounced avoidance of sunshine (eg reporting of allergy to the sun) Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion, Special dietary habits used by a small part of the population (veganism, low-carb high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded) Diets prescribed by the medical profession Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases Other diseases and conditions that affect the absorption and synthesis of vitamin D Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium), The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D, Visiting the solarium in the last three months before joining the survey, Mental incapacity that precludes adequate understanding or cooperation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Žmitek, PhD
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition Institute, Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mdpi.com/2072-6643/12/5/1268/htm
Description
Study results: Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level

Learn more about this trial

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

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