Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/01/2011
Date assigned
11/04/2011
Last edited
11/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lorraine Brennan

ORCID ID

Contact details

UCD Conway Institute
Belfield
Dublin
D4
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An investigation of the effect of introducing vitamin D2 enriched mushrooms in the diet: a randomised double-blind placebo-controlled dietary intervention study

Acronym

MMD

Study hypothesis

To ascertain if daily consumption of vitamin D2 enriched mushrooms can increase vitamin D status in free living healthy adults.

Ethics approval

Human Research Ethics Committee in University College Dublin (UCD) approved on the 24th November 2010 (ref: LS-10-152-Brennan-Gibney)

Study design

Randomised double-blind placebo-controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vitamin D supplementation

Intervention

Participants will be randomised to one of four treatment groups. The four treatment groups are defined as follows:
Group 1: daily vitamin D2 enriched mushrooms
Group 2: daily standard mushrooms
Group 3: daily vitamin D3 capsule (15 µg)
Group 4: daily vitamin D placebo capsule

Total duration of intervention: 4 weeks

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D2

Primary outcome measures

Circulating concentration of vitamin D, performed pre- and post- 4-week intervention

Secondary outcome measures

Metabolites relating to glucose and lipid metabolism, performed pre- and post- 4-week intervention

Overall trial start date

26/01/2011

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male and females free-living Caucasians aged 30 - 65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Body mass index (BMI) less than 18.0 or 31.0 (kg/m2)
2. Any chronic or infectious disease
3. Any prescribed medication (contraceptive pills and hormone replacement therapy will be permitted)
4. Pregnant or lactating females

Recruitment start date

26/01/2011

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Ireland

Trial participating centre

UCD Conway Institute
Dublin
D4
Ireland

Sponsor information

Organisation

University College Dublin (UCD) (Ireland)

Sponsor details

Belfield
Dublin
D4
Ireland

Sponsor type

University/education

Website

http://www.ucd.ie/

Funders

Funder type

Industry

Funder name

Monaghan Mushrooms (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes