Randomized double-blind trial of diamine-oxidase (DAO) food supplement to treat patients with episodic migraine and DAO deficiency
| ISRCTN | ISRCTN10091019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10091019 |
| Secondary identifying numbers | MigraDAO 002 |
- Submission date
- 08/12/2016
- Registration date
- 15/12/2016
- Last edited
- 02/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
A migraine is a type of headache disorder which involves suffering from recurrent headaches that are moderate to severe. These headaches are usually felt as a throbbing pain on one side of the head and can be coupled with visual disturbances and nausea. The exact cause of migraines are unknown, however many believe it is related to histamine, a chemical produced by the immune system cells which help the body to get rid of something that is triggering an allergy. The breakdown of histamine involved different processes, including use of the enzyme diamine-oxidase (DAO). Low activity of DAO is related to the build-up of histamine in the body, which could cause migraines. The aim of this study is to find out whether treatment with DAO is an effective treatment for migraines.
Who can participate?
Adults who have suffered between four and fourteen migraines a month for at least six months.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated with DAO 20 minutes before breakfast, lunch and dinner for a total of one month. Those in the second group are treated with a placebo (dummy drug) 20 minutes before breakfast, lunch and dinner for a total of one month. Throughout the treatment period and for a further month, participants in both groups keep diaries recording the number of migraine attacks, duration of the attacks, intensity and treatment used.
What are the possible benefits and risks of participating?
There are no known benefits or risks involved with participating.
Where is the study run from?
Hospital General de Catalunya (Spain)
When is the study starting and how long is it expected to run for?
February 2011 to January 2013
Who is funding the study?
DR Healthcare (Spain)
Who is the main contact?
Dr Joan Izquierdo
jizquierdo@hgc.es
Contact information
Scientific
Hospital General de Catalunya
Calle Pedro i Pons, 1
Sant Cugat del Valles
080195
Spain
| Phone | +34 606 416 148 |
|---|---|
| jizquierdo@hgc.es |
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Double blinded trial, comparative and controlled with placebo, to evaluate the efficiency of supplementation with diamino-oxidase versus placebo in the prophylactic treatment of migraine |
| Study hypothesis | Patients with migraine have a low activity of diamino-oxidase, and enzymatic supplementation could improve the symptoms. |
| Ethics approval(s) | Ethics Committee of the Hospital General de Catalunya, 10/08/2011, ref: V.1.1julio2011 MIGRADAO-002 |
| Condition | Patients with migraine and deficit in the activity of the Diamine-oxidase. |
| Intervention | Participants are randomised to one of two groups using the RANUNI procedure (SAS v. 6.12, SAS Institute, Cary, NC, USA). Group 1: Participants are treated with 14mg diamine-oxidase 20 minutes before breakfast, lunch and dinner for one month Group 2: Participants are treated with a placebo 20 minutes before breakfast, lunch and dinner for one month Participants in both groups are followed up for for one month after the treatment period. During this time, participants record the number of migraine attacks, duration of the attacks, intensity and treatment used. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Hours of headache per month are measured using patient diaries at baseline and after 4 weeks of observation and after 4 weeks of treatment 2. Number of migraine crisis during the month are measured using patient diaries at baseline and after 4 weeks of treatment |
| Secondary outcome measures | 1. Intensity of pain measured using a visual analogue scale at baseline and after 4 weeks of treatment 2. Number and type of analgesic used during the month is measured using patient diaries baseline and after 4 weeks of treatment |
| Overall study start date | 01/02/2011 |
| Overall study end date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Age between 18 and 65 years old 2. 4-14 migraine episodes per month for a minimum of six months prior to study initiation |
| Participant exclusion criteria | 1. Beginning of migraines when participant was over 50 years old 2. Other kind of headaches diagnosed in the same patient 3. Possibility of pregnancy 4. Preventive treatment for episodic migraine during three months prior the study |
| Recruitment start date | 01/08/2011 |
| Recruitment end date | 31/07/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
Sant Cugat del Valles (Barcelona)
08190
Spain
Sponsor information
Industry
Escoles Pies 29
Barcelona
08017
Spain
| Phone | +34 935 533 692 |
|---|---|
| jjduelo@dr-healthcare.com | |
| Website | www.dr-healthcare.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Primary results were accepted and presented as an oral communication in the World Neurological Congress in Wien 2013. Planned publication in a high level impact publication in the field of nutrition. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mari Luz Latorre (mariluzlatorreb.edu) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | publication results | 01/02/2019 | Yes | No |
Editorial Notes
02/03/2018: Publication reference added.
