Antioxidant-rich dietary intervention for improving asthma control in pregnancies complicated by asthma: study protocol for a randomized controlled trial

Trials

Vicki L Clifton²  Lisa G Wood¹  Jessica A Grieger² 

[1] Hunter Medical Research Institute, School of Biomedical Science and Pharmacy, University of Newcastle, Kookaburra Circuit, New Lambton Heights, NSW 2305, Australia;Robinson Institute, School of Paediatrics and Reproductive Health, Adelaide University, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112, Australia

关键词: Diet;    Asthma control;    Asthma;    Pregnancy;    Antioxidants;   

Others  :  807086
DOI  :  10.1186/1745-6215-15-108

 received in 2013-08-28, accepted in 2014-03-24,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Grieger et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Hart PH: Regulation of the inflammatory response in asthma by mast cell products. Immunol Cell Biol 2001, 79:149-153.
• [2]Killeen K, Skora E: Pathophysiology, diagnosis, and clinical assessment of asthma in the adult. Nurs Clin North Am 2013, 48:11-23.
• [3]Wood LG, Gibson PG, Garg ML: Biomarkers of lipid peroxidation, airway inflammation and asthma. Eur Respir J 2003, 21:177-186.
• [4]Nadeem A, Chhabra SK, Masood A, Raj HG: Increased oxidative stress and altered levels of antioxidants in asthma. J Allergy Clin Immunol 2003, 111:72-78.
• [5]Riccioni G, Bucciarelli T, Mancini B, Di Ilio C, Della Vecchia R, D’Orazio N: Plasma lycopene and antioxidant vitamins in asthma: the PLAVA study. J Asthma 2007, 44:429-432.
• [6]Shanmugasundaram KR, Kumar SS, Rajajee S: Excessive free radical generation in the blood of children suffering from asthma. Clin Chim Acta 2001, 305:107-114.
• [7]Wood LG, Gibson PG: Reduced circulating antioxidant defences are associated with airway hyper-responsiveness, poor control and severe disease pattern in asthma. Br J Nutr 2010, 103:735-741.
• [8]Bucchieri F, Puddicombe SM, Lordan JL, Richter A, Buchanan D, Wilson SJ, Ward J, Zummo G, Howarth PH, Djukanovic R, Holgate ST, Davies DE: Asthmatic bronchial epithelium is more susceptible to oxidant-induced apoptosis. Am J Respir Cell Mol Biol 2002, 27:179-185.
• [9]Jayaram L, Chunilal S, Pickering S, Ruffin RE, Zalewski PD: Sputum zinc concentration and clinical outcome in older asthmatics. Respirology 2011, 16:459-466.
• [10]Wood LG, Garg ML, Powell H, Gibson PG: Lycopene-rich treatments modify noneosinophilic airway inflammation in asthma: proof of concept. Free Radic Res 2008, 42:94-102.
• [11]Wood LG, Garg ML, Smart JM, Scott HA, Barker D, Gibson PG: Manipulating antioxidant intake in asthma: a randomized controlled trial. Am J Clin Nutr 2012, 96:534-543.
• [12]Kaur B, Rowe BH, Arnold E: Vitamin C supplementation for asthma. Cochrane Database Syst Rev 2009, 1:CD000993.
• [13]Pearson PJ, Lewis SA, Britton J, Fogarty A: Vitamin E supplements in asthma: a parallel group randomised placebo controlled trial. Thorax 2004, 59:652-656.
• [14]Shaheen SO, Newson RB, Rayman MP, Wong AP, Tumilty MK, Phillips JM, Potts JF, Kelly FJ, White PT, Burney PG: Randomised, double blind, placebo-controlled trial of selenium supplementation in adult asthma. Thorax 2007, 62:483-490.
• [15]Clark JM, Hulme E, Devendrakumar V, Turner MA, Baker PN, Sibley CP, D’Souza SW: Effect of maternal asthma on birthweight and neonatal outcome in a British inner-city population. Paediatr Perinat Epidemiol 2007, 21:154-162.
• [16]Kurinczuk JJ, Parsons DE, Dawes V, Burton PR: The relationship between asthma and smoking during pregnancy. Women Health 1999, 29:31-47.
• [17]Kwon HL, Belanger K, Bracken MB: Asthma prevalence among pregnant and childbearing-aged women in the United States: estimates from national health surveys. Ann Epidemiol 2003, 13:317-324.
• [18]Murphy VE, Namazy JA, Powell H, Schatz M, Chambers C, Attia J, Gibson PG: A meta-analysis of adverse perinatal outcomes in women with asthma. BJOG 2011, 118:1314-1323.
• [19]Murphy VE, Gibson P, Talbot PI, Clifton VL: Severe asthma exacerbations during pregnancy. Obstet Gynecol 2005, 106:1046-1054.
• [20]Toescu V, Nuttall SL, Martin U, Kendall MJ, Dunne F: Oxidative stress and normal pregnancy. Clin Endocrinol (Oxf) 2002, 57:609-613.
• [21]Ishihara O, Hayashi M, Osawa H, Kobayashi K, Takeda S, Vessby B, Basu S: Isoprostanes, prostaglandins and tocopherols in pre-eclampsia, normal pregnancy and non-pregnancy. Free Radic Res 2004, 38:913-918.
• [22]Myatt L, Cui X: Oxidative stress in the placenta. Histochem Cell Biol 2004, 122:369-382.
• [23]Wang YP, Walsh SW, Guo JD, Zhang JY: Maternal levels of prostacyclin, thromboxane, vitamin E, and lipid peroxides throughout normal pregnancy. Am J Obstet Gynecol 1991, 165:1690-1694.
• [24]Clifton VL, Vanderlelie J, Perkins AV: Increased anti-oxidant enzyme activity and biological oxidation in placentae of pregnancies complicated by maternal asthma. Placenta 2005, 26:773-779.
• [25]Osei-Kumah A, Wark PA, Smith R, Clifton VL: Asthma during pregnancy alters immune cell profile and airway epithelial chemokine release. Inflamm Res 2010, 59:349-358.
• [26]Seaton A, Godden DJ, Brown K: Increase in asthma: a more toxic environment or a more susceptible population? Thorax 1994, 49:171-174.
• [27]Ni Mhurchu C, Lawes C: National food supply: a major opportunity to improve population health. N Z Med J 2005, 118:U1750.
• [28]UK Department of Environment, Food and Rural Affairs: Family Food 2010. London, UK: Department for Environment, Food and Rural Affairs; 2011. Available online: http://webarchive.nationalarchives.gov.uk/20130103014432/http://www.defra.gov.uk/statistics/files/defra-stats-foodfarm-food-familyfood-2010-120328.pdf webcite
• [29]Erkkola M, Nwaru BI, Kaila M, Kronberg-Kippila C, Ilonen J, Simell O, Veijola R, Knip M, Virtanen SM: Risk of asthma and allergic outcomes in the offspring in relation to maternal food consumption during pregnancy: a Finnish birth cohort study. Pediatr Allergy Immunol 2012, 23:186-194.
• [30]Nwaru BI, Erkkola M, Lumia M, Kronberg-Kippila C, Ahonen S, Kaila M, Ilonen J, Simell O, Knip M, Veijola R, Virtanen SM: Maternal intake of fatty acids during pregnancy and allergies in the offspring. Br J Nutr 2012, 108:720-732.
• [31]Rodriguez-Bernal CL, Rebagliato M, Iniguez C, Vioque J, Navarrete-Munoz EM, Murcia M, Bolumar F, Marco A, Ballester F: Diet quality in early pregnancy and its effects on fetal growth outcomes: the Infancia y Medio Ambiente (Childhood and Environment) Mother and Child Cohort Study in Spain. Am J Clin Nutr 2010, 91:1659-1666.
• [32]Knudsen VK, Orozova-Bekkevold IM, Mikkelsen TB, Wolff S, Olsen SF: Major dietary patterns in pregnancy and fetal growth. Eur J Clin Nutr 2008, 62:463-470.
• [33]Thompson JM, Wall C, Becroft DM, Robinson E, Wild CJ, Mitchell EA: Maternal dietary patterns in pregnancy and the association with small-for-gestational-age infants. Br J Nutr 2010, 103:1665-1673.
• [34]Haider BA, Yakoob MY, Bhutta ZA: Effect of multiple micronutrient supplementation during pregnancy on maternal and birth outcomes. BMC Public Health 2011, 11(Suppl 3):S19. BioMed Central Full Text
• [35]Thorne-Lyman A, Fawzi WW: Vitamin D during pregnancy and maternal, neonatal and infant health outcomes: a systematic review and meta-analysis. Paediatr Perinat Epidemiol 2012, 26(Suppl 1):75-90.
• [36]Dror DK, Allen LH: Interventions with vitamins B6, B12 and C in pregnancy. Paediatr Perinat Epidemiol 2012, 26(Suppl 1):55-74.
• [37]Greenough A, Shaheen SO, Shennan A, Seed PT, Poston L: Respiratory outcomes in early childhood following antenatal vitamin C and E supplementation. Thorax 2010, 65:998-1003.
• [38]Villar J, Purwar M, Merialdi M, Zavaleta N, Thi Nhu Ngoc N, Anthony J, De Greeff A, Poston L, Shennan A: World Health Organisation multicentre randomised trial of supplementation with vitamins C and E among pregnant women at high risk for pre-eclampsia in populations of low nutritional status from developing countries. BJOG 2009, 116:780-788.
• [39]Thorne-Lyman AL, Fawzi WW: Vitamin A and carotenoids during pregnancy and maternal, neonatal and infant health outcomes: a systematic review and meta-analysis. Paediatr Perinat Epidemiol 2012, 26(Suppl 1):36-54.
• [40]Hovdenak N, Haram K: Influence of mineral and vitamin supplements on pregnancy outcome. Eur J Obstet Gynecol Reprod Biol 2012, 164:127-132.
• [41]Rumbold A, Duley L, Crowther CA, Haslam RR: Antioxidants for preventing pre-eclampsia. Cochrane Database Syst Rev 2008, 1:CD004227.
• [42]McLernon PC, Wood LG, Murphy VE, Hodyl NA, Clifton VL: Circulating antioxidant profile of pregnant women with asthma. Clin Nutr 2012, 31:99-107.
• [43]Juniper EF, O’Byrne PM, Guyatt GH, Ferrie PJ, King DR: Development and validation of a questionnaire to measure asthma control. Eur Respir J 1999, 14:902-907.
• [44]Powell H, Smart J, Wood LG, Grissell T, Shafren DR, Hensley MJ, Gibson PG: Validity of the common cold questionnaire (CCQ) in asthma exacerbations. PLoS One 2008, 3:e1802.
• [45]National Asthma Council Australia: Australian Asthma Handbook. 2014. [Version 1.0. National Asthma Council Australia, Melbourne] Available online: http://www.asthmahandbook.org.au webcite. Published by National Asthma Council Australia Ltd
• [46]Murphy VE, Clifton VL, Gibson PG: The effect of cigarette smoking on asthma control during exacerbations in pregnant women. Thorax 2010, 65:739-744.
• [47]Murphy VE, Gibson PG, Talbot PI, Kessell CG, Clifton VL: Asthma self-management skills and the use of asthma education during pregnancy. Eur Respir J 2005, 26:435-441.
• [48]Powell H, Murphy VE, Taylor DR, Hensley MJ, McCaffery K, Giles W, Clifton VL, Gibson PG: Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet 2011, 378:983-990.
• [49]Neumark-Sztainer D, Story M, Hannan PJ, Perry CL, Irving LM: Weight-related concerns and behaviors among overweight and nonoverweight adolescents: implications for preventing weight-related disorders. Arch Pediatr Adolesc Med 2002, 156:171-178.
• [50]Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS: Development and validation of a pregnancy physical activity questionnaire. Med Sci Sports Exerc 2004, 36:1750-1760.
• [51]Wood LG, Garg ML, Blake RJ, Garcia-Caraballo S, Gibson PG: Airway and circulating levels of carotenoids in asthma and healthy controls. J Am Coll Nutr 2005, 24:448-455.
• [52]Wood LG, Fitzgerald DA, Gibson PG, Cooper DM, Garg ML: Increased plasma fatty acid concentrations after respiratory exacerbations are associated with elevated oxidative stress in cystic fibrosis patients. Am J Clin Nutr 2002, 75:668-675.