AsthmaNCT01661530
Piloting a Dietary Vitamin E Intervention During Pregnancy
A study testing Vitamin E enhanced soup and Non-enhanced soups in people with Asthma, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
In the last forty years the prevalence of asthma has increased in westernised countries. We have hypothesised that this increase may be a consequence of changing diet. Several birth cohort studies have now reported an association between reduced maternal vitamin E intake during pregnancy and childhood asthma. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Vitamin E enhanced soup and Non-enhanced soups
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 10-12 weeks pregnant.
- Routine low risk antenatal care.
- A personal or partner history of asthma at anytime.
- Able and willing to give informed consent to participate
- Able and willing to participate in the study procedures
Who cannot join
- Use of vitamin E supplements.
- A history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel, cholestyramine, cyclosporin A, gemfibrozil, isoniazid, orlistat, anticonvulsants.
- Any other significant disease or disorder which, in the opinion of the investigator, either puts the woman at risk because of participating in the study or may influence the results of the study, or the woman's ability to participate in the study.
- Participating in another clinical study
- Previous allocation of randomisation code in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Maternity Hospital
Aberdeen, Aberdeen, AB25 2ZN
About this study
Official title: A Double Blind Randomised Placebo Controlled Pilot Study of a Dietary Soup Intervention During Pregnancy to Optimise Dietary Vitamin E Intake in Relation to Childhood Asthma.
In the last forty years the prevalence of asthma has increased in westernised countries. We have hypothesised that this increase may be a consequence of changing diet. Several birth cohort studies have now reported an association between reduced maternal vitamin E intake during pregnancy and childhood asthma.
However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy reduces the risk of childhood asthma. We are planning a large placebo controlled trial in pregnant women, to investigate whether optimisation of dietary vitamin E intake to the recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary intervention using vitamin E in its natural form of food is more likely to be successful and acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women can optimise their vitamin E intake using a personalised dietary plan with the help of a dietitian however this intervention was complex and could not be translated into everyday use. With commercial support we have developed a range of soups containing foods naturally rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of similar tasting and looking placebo soups has also been developed. In this study we will pilot a randomised controlled trial of the active and placebo soups to ascertain whether pregnant women are willing and able to optimise their vitamin E intake during pregnancy using the soups in order to reduce the risk of their child developing asthma. optimising maternal vitamin E intake during pregnancy.
- Conditions
- Asthma
- Being tested
- Vitamin E enhanced soup, Non-enhanced soups
- Keywords
- asthma, pregnancy, diet, vitamin E
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E enhanced soupDietary supplement
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
Non-enhanced soupsDietary supplement
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E enhanced diet | Experimental | Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week Receives: Dietary Supplement: Vitamin E enhanced soup |
| Non-enhanced dietary intervention | Placebo comparator | Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week Receives: Dietary Supplement: Non-enhanced soups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
Measured: 1 year
Secondary outcomes (2)
Dietary vitamin E intake during pregnancy.
Measured: 1 year
Lung function of new born infants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graham Devereux, MD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661530
- Sponsor's protocol ID
- 2/0036/12
- Other IDs
- 12/NS/0053
- Status last verified
- Jan 2014
- First submitted
- 7 Aug 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Devereux G, Turner SW, Craig LC, McNeill G, Martindale S, Harbour PJ, Helms PJ, Seaton A. Low maternal vitamin E intake during pregnancy is associated with asthma in 5-year-old children. Am J Respir Crit Care Med. 2006 Sep 1;174(5):499-507. doi: 10.1164/rccm.200512-1946OC. Epub 2006 Jun 8.
PubMed 16763215Litonjua AA, Rifas-Shiman SL, Ly NP, Tantisira KG, Rich-Edwards JW, Camargo CA Jr, Weiss ST, Gillman MW, Gold DR. Maternal antioxidant intake in pregnancy and wheezing illnesses in children at 2 y of age. Am J Clin Nutr. 2006 Oct;84(4):903-11. doi: 10.1093/ajcn/84.4.903.
PubMed 17023719
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Placebo Controlled Pilot Study of a Dietary Soup Intervention During Pregnancy to Optimise Dietary Vitamin E Intake in Relation to Childhood Asthma.
- ClinicalTrials.gov ID
- NCT01661530
- Acronym / sponsor ID
- 2/0036/12
- Conditions
- Asthma
- Keywords
- asthma, pregnancy, diet, vitamin E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the last forty years the prevalence of asthma has increased in westernised countries. We have hypothesised that this increase may be a consequence of changing diet. Several birth cohort studies have now reported an association between reduced maternal vitamin E intake during pregnancy and childhood asthma.
However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy reduces the risk of childhood asthma. We are planning a large placebo controlled trial in pregnant women, to investigate whether optimisation of dietary vitamin E intake to the recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary intervention using vitamin E in its natural form of food is more likely to be successful and acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women can optimise their vitamin E intake using a personalised dietary plan with the help of a dietitian however this intervention was complex and could not be translated into everyday use. With commercial support we have developed a range of soups containing foods naturally rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of similar tasting and looking placebo soups has also been developed. In this study we will pilot a randomised controlled trial of the active and placebo soups to ascertain whether pregnant women are willing and able to optimise their vitamin E intake during pregnancy using the soups in order to reduce the risk of their child developing asthma. optimising maternal vitamin E intake during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E enhanced diet | Experimental | Dietary Supplement: Vitamin E enhanced soupRange of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week |
| Non-enhanced dietary intervention | Placebo comparator | Dietary Supplement: Non-enhanced soupsRange of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 10-12 weeks pregnant.
- Routine low risk antenatal care.
- A personal or partner history of asthma at anytime.
- Able and willing to give informed consent to participate
- Able and willing to participate in the study procedures
Key exclusion criteria (5 listed)
- Use of vitamin E supplements.
- A history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel, cholestyramine, cyclosporin A, gemfibrozil, isoniazid, orlistat, anticonvulsants.
- Any other significant disease or disorder which, in the opinion of the investigator, either puts the woman at risk because of participating in the study or may influence the results of the study, or the woman's ability to participate in the study.
- Participating in another clinical study
- Previous allocation of randomisation code in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E enhanced soupvitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients | Dietary supplement | Vitamin E enhanced diet |
| Non-enhanced soupsSimilar looking and tasting soups with low vitamin E content by virtue of food ingredients | Dietary supplement | Non-enhanced dietary intervention |
Primary outcome
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
Time frame: 1 year
2 secondary outcomes
Dietary vitamin E intake during pregnancy.
Time frame: 1 year
Lung function of new born infants.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 16763215Devereux G, Turner SW, Craig LC, McNeill G, Martindale S, Harbour PJ, Helms PJ, Seaton A. Low maternal vitamin E intake during pregnancy is associated with asthma in 5-year-old children. Am J Respir Crit Care Med. 2006 Sep 1;174(5):499-507. doi: 10.1164/rccm.200512-1946OC. Epub 2006 Jun 8.
- Background: PubMed 17023719Litonjua AA, Rifas-Shiman SL, Ly NP, Tantisira KG, Rich-Edwards JW, Camargo CA Jr, Weiss ST, Gillman MW, Gold DR. Maternal antioxidant intake in pregnancy and wheezing illnesses in children at 2 y of age. Am J Clin Nutr. 2006 Oct;84(4):903-11. doi: 10.1093/ajcn/84.4.903.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Devereux, MD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E enhanced soup and Non-enhanced soups in people with Asthma, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661530, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.