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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Oil-based vitamin D; Dietary supplement: Water-based vitamin D; Dietary supplement: Vitamin D capsules

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Nutrition Institute, Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in vitamin D serum concentration after 8 weeks of supplementation	8 weeks

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: Slovenian Research Agency; Higher School of Applied Sciences (VIST); Valens Int. d.o.o., Slovenija
• Investigators: Principal Investigator: Katja Žmitek, PhD, Researcher

Publications and helpful links

Helpful Links

• Study results: Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: VITAD-01-2018 Part 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No