NCT02631629

Brief Summary

This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

November 11, 2015

Last Update Submit

October 17, 2016

Conditions

Vitamin D Deficiency

Keywords

Vitamin DFortification

Outcome Measures

Primary Outcomes (1)

  • The change in vitamin D status measured as serum 25-hydroxyvitamin D

    12 weeks

Study Arms (4)

Non-fortified foods SA

PLACEBO COMPARATOR

Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin

Other: Non-fortified foods

Non-fortified foods CA

PLACEBO COMPARATOR

Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin

Other: Non-fortified foods

Vitamin D fortified foods SA

ACTIVE COMPARATOR

Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin

Other: Fortified foods

Vitamin D fortified foods CA

ACTIVE COMPARATOR

Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin

Other: Fortified foods

Interventions

Non-fortified foodsOTHER

The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).

Non-fortified foods CANon-fortified foods SA
Fortified foodsOTHER

The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).

Vitamin D fortified foods CAVitamin D fortified foods SA

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old women
  • Low consumption of fish and fish products
  • Low intake of vitamin D containing supplements
  • No use of sunning facilities
  • No planned sun-holiday between October 2015 and May 2016

You may not qualify if:

  • Pregnancy and breastfeeding
  • Menopause
  • Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Denmark

Søborg, 2860, Denmark

Location

Related Publications (1)

  • Gronborg IM, Tetens I, Christensen T, Andersen EW, Jakobsen J, Kiely M, Cashman KD, Andersen R. Vitamin D-fortified foods improve wintertime vitamin D status in women of Danish and Pakistani origin living in Denmark: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):741-753. doi: 10.1007/s00394-019-01941-6. Epub 2019 Mar 9.

    PMID: 30852657DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Food, Fortified

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Inge Tetens, Professor

    Technical University of Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2015

First Posted

December 16, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

DK(1)