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

NCT03810261 | Completed

• 1 other identifier: VITAD-01-2018 Part 2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in vitamin D serum concentration after 8 weeks of supplementation

  8 weeks

Study Arms (4)

Oil-based vitamin D group

EXPERIMENTAL

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

Dietary Supplement: Oil-based vitamin D

Water-based vitamin D group

EXPERIMENTAL

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

Dietary Supplement: Water-based vitamin D

Vitamin D capsules group

EXPERIMENTAL

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

Dietary Supplement: Vitamin D capsules

Control group

NO INTERVENTION

This group will receive no intervention.

Interventions

Oil-based vitamin D DIETARY_SUPPLEMENT

Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.

Oil-based vitamin D group

Water-based vitamin D DIETARY_SUPPLEMENT

Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.

Water-based vitamin D group

Vitamin D capsules DIETARY_SUPPLEMENT

Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.

Vitamin D capsules group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• VIST - Faculty of Applied Sciences: collaborator
• Slovenian Research Agency: collaborator
• Valens Int. d.o.o., Slovenija: collaborator

Study Sites (1)

Nutrition Institute, Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Katja Žmitek, PhD

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 18, 2019
• Study Start: January 8, 2019
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)