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
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