Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

A factorial randomized controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal endothelium-dependent vasodilatation and oxidative stress of the newborn

Authors: Robinson Ramírez-Vélez, Miryam Romero, Isabella Echeverri, José Guillermo Ortega, Mildrey Mosquera, Blanca Salazar, Sandra Lorena Girón, Wilmar Saldarriaga, Ana Cecilia Aguilar de Plata, Julio Cesar Mateus

Published in: Trials | Issue 1/2011

Login to get access

Abstract

Background

Many studies have suggested a relationship between metabolic abnormalities and impaired fetal growth with the development of non-transmissible chronic diseases in the adulthood. Moreover, it has been proposed that maternal factors such as endothelial function and oxidative stress are key mechanisms of both fetal metabolic alterations and subsequent development of non-transmissible chronic diseases. The objective of this project is to evaluate the effect of micronutrient supplementation and regular aerobic exercise on endothelium-dependent vasodilation maternal and stress oxidative of the newborn.

Methods and design

320 pregnant women attending to usual prenatal care in Cali, Colombia will be included in a factorial randomized controlled trial. Women will be assigned to the following intervention groups: 1. Control group: usual prenatal care (PC) and placebo (maltodextrine). 2. Exercise group: PC, placebo and aerobic physical exercise. 3. Micronutrients group: PC and a micronutrients capsule consisting of zinc (30 mg), selenium (70 μg), vitamin A (400 μg), alphatocopherol (30 mg), vitamin C (200 mg), and niacin (100 mg). 4. Combined interventions Group: PC, supplementation of micronutrients, and aerobic physical exercise. Anthropometric measures will be taken at the start and at the end of the interventions.

Discussion

Since in previous studies has been showed that the maternal endothelial function and oxidative stress are related to oxidative stress of the newborn, this study proposes that complementation with micronutrients during pregnancy and/or regular physical exercise can be an early and innovative alternative to strengthen the prevention of chronic diseases in the population.

Trial registration

NCT00872365.
Appendix
Available only for authorised users
Literature
1.
Sharkey D, Gardner DS, Symonds ME, Budge H: Maternal nutrient restriction during early fetal kidney development attenuates the renal innate inflammatory response in obese young adult offspring. Am J Physiol Renal Physiol. 2009, 297: F1199-207. 10.1152/ajprenal.00303.2009.CrossRefPubMedPubMedCentral
2.
Mensah GA, Catravas JD, Engelgau MM, Hooper WC, Madeddu P, Ryan US, She JX, Reed E, Vinicor F, Yacoub MH: Vascular endothelium summary statement VI: Research directions for the 21st century. Vascul Pharmacol. 2007, 46: 330-332. 10.1016/j.vph.2006.10.016.CrossRefPubMed
3.
Mensah G: Healthy endothelium: The scientific basis for cardiovascular health promotion and chronic disease prevention. Vascul Pharmacol. 2006, 46: 310-314. 10.1016/j.vph.2006.10.013.CrossRefPubMed
4.
Hooper WC, Catravas JD, Heistad DD, Sessa WC, Mensah GA: Vascular endothelium summary statement I: Health promotion and chronic disease prevention. Vascul Pharmacol. 2007, 46: 315-317. 10.1016/j.vph.2006.10.014.CrossRefPubMed
5.
Verhaar M, Rabelink T: The endothelium: a gynecological and obstetric point of view. Eur J Obstet Gynecol Reprod Biol. 2001, 94: 180-185. 10.1016/S0301-2115(00)00334-1.CrossRefPubMed
6.
Lopez-Garcia E, Schulze MB, Fung TT, Meigs JB, Rifai N, Manson JE, Hu FB: Major dietary patterns are related to plasma concentrations of markers of inflammation and endothelial dysfunction. Am J Clin Nutr. 2004, 80: 1029-1035.PubMed
7.
Horton ES: Effects of Lifestyle Changes to Reduce Risks of Diabetes and Associated Cardiovascular Risks: Results from Large Scale Efficacy Trials. Obesity (Silver Spring). 2009, 17 (n3s): S43-S48. 10.1038/oby.2009.388.CrossRef
8.
Teixeira V, Valente H, Casal S, Marques F, Moreira P: Antioxidant status, oxidative stress, and damage in elite trained kayakers and canoeists and sedentary controls. Int J Sport Nutr Exerc Metab. 2009, 5: 443-456.
9.
Di Francescomarino S, Sciartilli A, Di Valerio V, Di Baldassarre A, Gallina S: The effect of physical exercise on endothelial function. Sports Med. 2009, 39: 797-812. 10.2165/11317750-000000000-00000.CrossRef
10.
Song Y, Li TY, van Dam RM, Manson JE, Hu FB: Magnesium intake and plasma concentrations of markers of systemic inflammation and endothelial dysfunction in women. Am J Clin Nutr. 2007, 85: 1068-1074.PubMed
11.
Yeo S: A randomized comparative trial of the efficacy and safety of exercise during pregnancy: Design and methods. Contemp Clin Trials. 2006, 27: 531-540. 10.1016/j.cct.2006.06.005.CrossRefPubMed
12.
Mostyn A, Symonds ME: Early programming of adipose tissue function: a large-animal perspective. Proc Nutr Soc. 2009, 68: 393-400. 10.1017/S002966510999022X.CrossRefPubMed
13.
Alderman BW, Zhao H, Holt VL, Watts DH, Beresford SA: Maternal Physical Activity in Pregnancy and Infant Size for Gestational Age. Ann Epidemiol. 1998, 8: 513-519. 10.1016/S1047-2797(98)00020-9.CrossRefPubMed
14.
Joseph K, Kramer M: Should we intervene to improve fetal and infant growth?. A life Course Approach to Chronic Disease Epidemiology. Edited by: Kuh D, Ben-Shlomo Y. 2004, New York: Oxford University Press, Second
15.
Hegaard HK, Pedersen BK, Nielsen BB, Damm P: Leisure time physical activity during pregnancy and impact on gestational diabetes mellitus, pre-eclampsia, preterm delivery and birth weight: a review. Acta Obstet Gynecol Scand. 2007, 86: 1290-1296. 10.1080/00016340701647341.CrossRefPubMed
16.
Gavard JA, Artal R: Effect of exercise on pregnancy outcome. Clin Obstet Gynecol. 2008, 51: 467-480. 10.1097/GRF.0b013e31816feb1d.CrossRefPubMed
17.
Herrera JA, Arevalo-Herrera M, Herrera S: Prevention of preeclampsia by linoleic acid and calcium supplementation: a randomized controlled trial. Obstet Gynecol. 1998, 91: 585-590. 10.1016/S0029-7844(97)00711-4.PubMed
18.
ACOG Committee on Obstetric Practice. ACOG Committee Opinion. Number 267, January 2002: Exercise during pregnancy and the postpartum period. Obstet Gynecol. 2002, 99: 171-173. 10.1016/S0029-7844(01)01749-5.CrossRef
19.
ACSM's: Guidelines for Exercise Testing and Prescription. 2000, Philadelphia, PA: Lippincott Williams & Wilkins, 6
20.
Wittes J: Sample Size Calculations for Randomized Controlled Trials. Epidemiol Rev. 2002, 24: 39-53. 10.1093/epirev/24.1.39.CrossRefPubMed
21.
Heymans MW, van Buuren S, Knol DL, van Mechelen W, de Vet HC: Variable selection under multiple imputation using the bootstrap in a prognostic study. BMC Med Res Methodol. 2007, 13 (7): 33-10.1186/1471-2288-7-33.CrossRef
22.
Graham JW: Missing Data Analysis: Making it Work in the Real World. Annu Rev Psychol. 2009, 60: 549-76. 10.1146/annurev.psych.58.110405.085530.CrossRefPubMed
23.
Wood AM, White IR: Thompson SG. Are Missing Outcome Data Adequatelt Handled? A Review of Published Randomized Controlled Trials in Major Medical Journals. Clin Trials. 2004, 1: 368-76. 10.1191/1740774504cn032oa.CrossRefPubMed
24.
Armitage P, Berry G, Further Experimental Designs: Statistical Methods in Medical Research. Edited by: Armitage P, Berry G. 1994, London: Blackwell Scientific Publications, 237-82. Third
25.
Sheskin D, Test 22. The Kruskall-Wallis One-Way Analysis of Variance by Ranks: Handbook of Parametric and Nonparametric Statistical Procedures. Edited by: Sheskin D. 2000, Boca Raton: CHAPMAN & HALL/CRC, 595-609. Second
26.
Kleinbaum DG, Kupper LL, Muller KE, Nizam A: Applied Regression Analysis and Other Multivariable Methods. 1998, Dubury Press: Pacific Grove
27.
Standarizaton of anthropometric measurements. The Airle (VA) consensus Conference. Champaign, 11: Human Kinetics. Edited by: Lohman T, Roche A, Martorel R. 1988, 39-80.
28.
Pickering TG: Recommendations for the use of home (self) and ambulatory blood pressure monitoring. American Society of Hypertension Ad Hoc Panel. Am J Hypertens. 1996, 9: 1-11. 10.1016/0895-7061(95)00341-X.CrossRefPubMed
29.
Kyle UG, Schutz Y, Dupertuis YM, Pichard C: Body composition interpretation. Contributions of the fat-free mass index and the body fat mass index. Nutrition. 2003, 19: 597-604. 10.1016/S0899-9007(03)00061-3.CrossRefPubMed
30.
Silva SY, Villamizar C, Villamizar N, Silva F, Luengas C, Casas JP, Villa-Roel C, López-Jaramillo P: Colombian study to assess the use of noninvasive determination of Endothelium-mediated vasodilation (CANDEV). II. Does location of the occlusion device affects Diagnostic accuracy?. Endothelium. 2005, 12: 107-111. 10.1080/10623320500189798.CrossRefPubMed
31.
Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R, International Brachial Artery Reactivity Task Force: International brachial artery reactivity task force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the international brachial artery reactivity task force. J Am Coll Cardiol. 2002, 39: 257-265. 10.1016/S0735-1097(01)01746-6.CrossRefPubMed
32.
Sorensen KE, Celermajer DS, Spiegelhalter DJ, Georgakopoulos D, Robinson J, Thomas O, Deanfield JE: Non-invasive measurement of human endothelium dependent arterial responses: accuracy and reproducibility. Br Heart J. 1995, 74: 247-253. 10.1136/hrt.74.3.247.CrossRefPubMedPubMedCentral
33.
Milne GL, Yin H, Brooks JD, Sanchez S, Jackson Roberts L, Morrow JD: Quantification of F2-isoprostanes in biological fluids and tissues as a measure of oxidant stress. Methods Enzymol. 2007, 433: 113-126. full_text.CrossRefPubMed
34.
Liu W, Morrow JD, Yin H: Quantification of F2-isoprostanes as a reliable index of oxidative stress in vivo using gas chromatography-mass spectrometry (GC-MS) method. Free Radic Biol Med. 2009, 47: 1101-1107. 10.1016/j.freeradbiomed.2009.07.028.CrossRefPubMedPubMedCentral
35.
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. 10.1249/01.MSS.0000142303.49306.0D.CrossRefPubMed
36.
Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J: Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components. Med Clin. 2008, 130: 726-735. 10.1157/13121076.CrossRef
37.
Barakat R, Stirling JR, Lucia A: Does exercise training during pregnancy affect gestational age? A randomised controlled trial. Br J Sports Med. 2008, 42: 674-648. 10.1136/bjsm.2008.047837.CrossRefPubMed
38.
Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group: Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008, 148: 295-309.CrossRefPubMed
39.
Ramírez-Vélez R, Aguilar AC, Mosquera M, García RG, Reyes LM, López-Jaramillo P: Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials. 2009, 10: 104-CrossRefPubMedPubMedCentral
40.
Echeverry I, Ramírez-Vélez R, Mosquera M, Mateus JC, Aguilar AC: Potencial efecto del ejercicio físico y del consumo de micronutrientes durante la gestación en factores maternos y placentarios asociados a Enfermedades Crónicas No transmisibles (ECNT) del adulto. Colomb Med. 2009, 40: 435-446.
Metadata
Title
A factorial randomized controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal endothelium-dependent vasodilatation and oxidative stress of the newborn
Authors
Robinson Ramírez-Vélez
Miryam Romero
Isabella Echeverri
José Guillermo Ortega
Mildrey Mosquera
Blanca Salazar
Sandra Lorena Girón
Wilmar Saldarriaga
Ana Cecilia Aguilar de Plata
Julio Cesar Mateus
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-60

Other articles of this Issue 1/2011

Trials 1/2011 Go to the issue

Study protocol

The utility of Aspirin in dukes C and high risk dukes B colorectal cancer - The ASCOLT study: study protocol for a randomized controlled trial

Study protocol

PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial

Research

The impact of clinical data on the evaluation of tibial fracture healing

Study protocol

Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

Research

Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury

Study protocol

LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial