An investigation of the effect of introducing vitamin D2 enriched mushrooms in the diet
| ISRCTN | ISRCTN16158244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16158244 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/01/2011
- Registration date
- 11/04/2011
- Last edited
- 11/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lorraine Brennan
Scientific
Scientific
UCD Conway Institute
Belfield
Dublin
D4
Ireland
Study information
| Study design | Randomised double-blind placebo-controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | MMD |
| Study objectives | To ascertain if daily consumption of vitamin D2 enriched mushrooms can increase vitamin D status in free living healthy adults. |
| Ethics approval(s) | Human Research Ethics Committee in University College Dublin (UCD) approved on the 24th November 2010 (ref: LS-10-152-Brennan-Gibney) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 26/01/2011 |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | Healthy male and females free-living Caucasians aged 30 - 65 years |
| Key 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 |
| Date of first enrolment | 26/01/2011 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- Ireland
Study participating centre
UCD Conway Institute
Dublin
D4
Ireland
D4
Ireland
Sponsor information
University College Dublin (UCD) (Ireland)
University/education
University/education
Belfield
Dublin
D4
Ireland
| Website | http://www.ucd.ie/ |
|---|---|
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Industry
Monaghan Mushrooms (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
