Clinical trial NCT00872365: Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
Official title: Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Pregnancy
Micronutrients
Exercise
Keywords: Pregnancy
Exercise
Nutrition
Micronutrients
non-transmissible chronic diseases
Endothelium
Lead sponsor: Universidad del Valle, Colombia
Sponsor class: OTHER
Collaborators: name: Fundación FES
name: Fundación Cardiovascular de Colombia
name: Instituto Nacional de Salud
name: University College, London
First posted: 2009-03-31
Enrollment: 320
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: At the moment, most of efforts to prevent non-transmissible chronic diseases at population level have been centered in promoting healthful behaviors like physical activity, consumption of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in adult population, but the results have been little hopeful. In the last years, manifold studies have indicated the relation between metabolic alterations and of the fetal growth with the development of non-transmissible chronic diseases in adult age. More recently, it has been proposed that maternal factors (endothelial function, oxidative stress and alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory mechanisms of fetal metabolic alterations and of the later development of non-transmissible chronic diseases. Also, it has been suggested that possibly supplementation with micronutrients and the physical exercise during the gestation can regulate these maternal and placental factors. For the reasons just mentioned, it is necessary to clarify if these proposed factors are related to fetal metabolic alterations and if the supplementation during the gestation with micronutrients and/or the physical exercise can regulate them, which would be an early and novel alternative to fortify the prevention of non-transmissible chronic diseases in the population.

Purpose

1. To evaluate the effect of associated both the maternal and placental metabolic factors to non-transmissible chronic diseases in newborn.
2. To evaluate the effect of the physical exercise and the complementation with micronutrients during the pregnancy either in the endothelial function, the levels of adipokines, the oxidative stress of the mother and the newborn, as in the placental mitochondrial function and the anthropometry of newborn.

Detailed description: Hypothesis:

1. There is correlation between the metabolic factors, related to non-transmissible chronic diseases, of the mother and those of the newborn one.
2. Supplementation with either micronutrients or physical exercise influence beneficially as much in the endothelial function, oxidative stress, the levels in adipokines of the mother and the newborn one like in the placental mitochondrial function.
3. The simultaneous intervention with micronutrients or physical exercise produces an additional beneficial effect in the metabolic state of the mother and the newborn one.
4. The metabolic alterations when being born are not exclusive of newborn with anthropometric measures located either in the inferior or superior percentiles.

Eligibility criteria: Inclusion Criteria:

* Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
* Live fetus at the routine ultrasound scan and a normal pregnancy.
* Gestational age 16 to 20 weeks
* Written informed consent will be obtained from each woman prior to the inclusion in the study.

Exclusion Criteria:

* History of high blood pressure
* Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
* Persistent bleeding after week 12 of gestation
* Poorly controlled thyroid disease
* Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
* History of miscarriage in the last twelve months
* Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).

Primary outcomes:
measure: Endothelium-dependent flow mediated dilation
timeFrame: Baseline / week 32-36 of gestation
Secondary outcomes:
measure: Biomarkers of endothelial function in blood from umbilical vein and maternal blood
timeFrame: Baseline / 32-36 weeks gestation and delivery
measure: Markers of mitochondrial function
timeFrame: Baseline / 32-36 weeks gestation and delivery
measure: Neonatal and maternal anthropometric indicators
timeFrame: Baseline / 32-36 weeks gestation and delivery
measure: Quality of life SF-12
timeFrame: Baseline / 32-36 weeks gestation and delivery
measure: Functional capacity (VO2max)
timeFrame: Baseline / 32-36 weeks gestation and delivery
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Ana C Plata, MSc
state: Valle Del Cauca
Study officials:
affiliation: Universidad del Valle, Colombia
name: Ana C Plata, MSc
role: STUDY_CHAIR
affiliation: Fundación FES, División de Salud. Colombia
name: Julio Cesar Mateus, MD, MEpi
role: STUDY_CHAIR
References:
citation: Robledo-Colonia AF, Sandoval-Restrepo N, Mosquera-Valderrama YF, Escobar-Hurtado C, Ramirez-Velez R. Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial. J Physiother. 2012;58(1):9-15. doi: 10.1016/S1836-9553(12)70067-X.
citation: Ramirez-Velez R, Romero M, Echeverri I, Ortega JG, Mosquera M, Salazar B, Giron SL, Saldarriaga W, Aguilar de Plata AC, Mateus JC. 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. Trials. 2011 Feb 28;12:60. doi: 10.1186/1745-6215-12-60.