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Antioxidant-rich dietary intervention for improving asthma control in pregnancies complicated by asthma: study protocol for a randomized controlled trial.
Trials 2014; 15:108T

Abstract

BACKGROUND

Asthma is the most prevalent chronic disease to complicate pregnancies worldwide, affecting around 12% of pregnant women in Australia. Oxidative stress and inflammation manifest during pregnancy; however asthma in pregnancies further intensifies oxidative stress. Consumption of antioxidant-rich foods has been shown to be beneficial for asthma control in non-pregnant asthmatic adults. It has not been investigated whether antioxidant-rich foods can improve the elevated oxidative stress that occurs with asthma in pregnancy, thereby improving asthma control. The primary aim of this study is to determine whether increased consumption of antioxidant-rich foods for 12 weeks will improve maternal asthma control, compared to standard dietary intake during pregnancy.

METHODS/DESIGN

A 12 week, parallel randomized controlled trial will be conducted. One hundred and sixty eight pregnant women with mild, moderate, or severe asthma, currently using inhaled corticosteroids, and with poor diet quality, will be recruited at approximately12 weeks gestation. Following a 4 week run-in period, women will be randomized to either a 12 week antioxidant intervention (increased consumption of antioxidant-rich foods (≥5 servings/day vegetables, ≥2 servings/day fruit, ≥8 ½ servings/day grains (mostly wholegrains), 3-4 serving/week lean meat) or standard pregnancy care. The primary outcome is asthma control score (decrease of 0.5, the minimally clinically significant change). Secondary outcomes include plasma antioxidants, markers of oxidative stress, and time to, and number of, exacerbations. With two-tailed t-tests at 80% power, a sample size of 52 completions per group is required. Allowing for a 78% retention including a 20% removal of women from the analysis due to non-compliance, we will recruit 168 women.

DISCUSSION

It is expected that this 12 week study will improve asthma control. This is significant because asthma is the most prevalent condition to complicate pregnancies and contributes to poor maternal, neonatal and infant health outcomes. Our research will provide the first evidence to show that, in pregnancy, consumption of antioxidant-rich foods is a key modifier of clinical asthma status. This research is crucial for contributing to the evidence base to inform future guidelines given existing clinical and research gaps.

TRIAL REGISTRATION

ACTRN12613000301763.

Authors+Show Affiliations

No affiliation info availableNo affiliation info availableRobinson Institute, School of Paediatrics and Reproductive Health, Adelaide University, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112, Australia. vicki.clifton@adelaide.edu.au.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24708597

Citation

Grieger, Jessica A., et al. "Antioxidant-rich Dietary Intervention for Improving Asthma Control in Pregnancies Complicated By Asthma: Study Protocol for a Randomized Controlled Trial." Trials, vol. 15, 2014, p. 108.
Grieger JA, Wood LG, Clifton VL. Antioxidant-rich dietary intervention for improving asthma control in pregnancies complicated by asthma: study protocol for a randomized controlled trial. Trials. 2014;15:108.
Grieger, J. A., Wood, L. G., & Clifton, V. L. (2014). Antioxidant-rich dietary intervention for improving asthma control in pregnancies complicated by asthma: study protocol for a randomized controlled trial. Trials, 15, p. 108. doi:10.1186/1745-6215-15-108.
Grieger JA, Wood LG, Clifton VL. Antioxidant-rich Dietary Intervention for Improving Asthma Control in Pregnancies Complicated By Asthma: Study Protocol for a Randomized Controlled Trial. Trials. 2014 Apr 4;15:108. PubMed PMID: 24708597.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antioxidant-rich dietary intervention for improving asthma control in pregnancies complicated by asthma: study protocol for a randomized controlled trial. AU - Grieger,Jessica A, AU - Wood,Lisa G, AU - Clifton,Vicki L, Y1 - 2014/04/04/ PY - 2013/08/28/received PY - 2014/03/24/accepted PY - 2014/4/9/entrez PY - 2014/4/9/pubmed PY - 2014/10/22/medline SP - 108 EP - 108 JF - Trials JO - Trials VL - 15 N2 - BACKGROUND: Asthma is the most prevalent chronic disease to complicate pregnancies worldwide, affecting around 12% of pregnant women in Australia. Oxidative stress and inflammation manifest during pregnancy; however asthma in pregnancies further intensifies oxidative stress. Consumption of antioxidant-rich foods has been shown to be beneficial for asthma control in non-pregnant asthmatic adults. It has not been investigated whether antioxidant-rich foods can improve the elevated oxidative stress that occurs with asthma in pregnancy, thereby improving asthma control. The primary aim of this study is to determine whether increased consumption of antioxidant-rich foods for 12 weeks will improve maternal asthma control, compared to standard dietary intake during pregnancy. METHODS/DESIGN: A 12 week, parallel randomized controlled trial will be conducted. One hundred and sixty eight pregnant women with mild, moderate, or severe asthma, currently using inhaled corticosteroids, and with poor diet quality, will be recruited at approximately12 weeks gestation. Following a 4 week run-in period, women will be randomized to either a 12 week antioxidant intervention (increased consumption of antioxidant-rich foods (≥5 servings/day vegetables, ≥2 servings/day fruit, ≥8 ½ servings/day grains (mostly wholegrains), 3-4 serving/week lean meat) or standard pregnancy care. The primary outcome is asthma control score (decrease of 0.5, the minimally clinically significant change). Secondary outcomes include plasma antioxidants, markers of oxidative stress, and time to, and number of, exacerbations. With two-tailed t-tests at 80% power, a sample size of 52 completions per group is required. Allowing for a 78% retention including a 20% removal of women from the analysis due to non-compliance, we will recruit 168 women. DISCUSSION: It is expected that this 12 week study will improve asthma control. This is significant because asthma is the most prevalent condition to complicate pregnancies and contributes to poor maternal, neonatal and infant health outcomes. Our research will provide the first evidence to show that, in pregnancy, consumption of antioxidant-rich foods is a key modifier of clinical asthma status. This research is crucial for contributing to the evidence base to inform future guidelines given existing clinical and research gaps. TRIAL REGISTRATION: ACTRN12613000301763. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/24708597/Antioxidant_rich_dietary_intervention_for_improving_asthma_control_in_pregnancies_complicated_by_asthma:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-108 DB - PRIME DP - Unbound Medicine ER -