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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 : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : March 15, 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

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE January 8, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Change in vitamin D serum concentration after 8 weeks of supplementation [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
Official Title  ICMJE Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Oil-based vitamin D group
    Oil-based vitamin D, 1000 IU/day for 8 weeks
    Intervention: Dietary Supplement: Oil-based vitamin D
  • Experimental: Water-based vitamin D group
    Water-based vitamin D, 1000 IU/day for 8 weeks
    Intervention: Dietary Supplement: Water-based vitamin D
  • Experimental: Vitamin D capsules group
    Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks
    Intervention: Dietary Supplement: Vitamin D capsules
  • No Intervention: Control group
    This group will receive no intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810261
Other Study ID Numbers  ICMJE VITAD-01-2018 Part 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nutrition Institute, Slovenia
Study Sponsor  ICMJE Nutrition Institute, Slovenia
Collaborators  ICMJE
  • Higher School of Applied Sciences (VIST)
  • Slovenian Research Agency
  • Valens Int. d.o.o., Slovenija
Investigators  ICMJE
Principal Investigator: Katja Žmitek, PhD Researcher
PRS Account Nutrition Institute, Slovenia
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP