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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
Sponsor:
Collaborators:
Higher School of Applied Sciences (VIST)
Slovenian Research Agency
Valens Int. d.o.o., Slovenija
Information provided by (Responsible Party):
Nutrition Institute, Slovenia

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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.



Primary Outcome Measures :
  1. Change in vitamin D serum concentration after 8 weeks of supplementation [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
Contact: Katja Žmitek, PhD 0038612831700 katja.zmitek@vist.si
Contact: Igor Pravst, PhD 0038659068870 igor.pravst@nutris.org

Locations
Slovenia
Nutrition Institute, Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Katja Žmitek    +386 1 283 1700    katja.zmitek@vist.si   
Contact: Igor Pravst, PhD    +386 590 68870    igor.pravst@nutris.org   
Principal Investigator: Katja Žmitek, PhD         
Sponsors and Collaborators
Nutrition Institute, Slovenia
Higher School of Applied Sciences (VIST)
Slovenian Research Agency
Valens Int. d.o.o., Slovenija
Investigators
Principal Investigator: Katja Žmitek, PhD Researcher

Responsible Party: Nutrition Institute, Slovenia
ClinicalTrials.gov Identifier: NCT03810261     History of Changes
Other Study ID Numbers: VITAD-01-2018 Part 2
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents