Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
Primary Purpose
Preeclampsia, Pregnancy, Micronutrients
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Regular aerobic physical exercise
Micronutrients
Activities of daily living + placebo
Sponsored by
About this trial
This is an interventional basic science trial for Preeclampsia focused on measuring Pregnancy, Exercise, Nutrition, Micronutrients, non-transmissible chronic diseases, Endothelium
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).
Sites / Locations
- Ana C Plata, MSc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Regular aerobic physical exercise + placebo
Activities of daily living + Micronutrients
Regular aerobic exercise + micronutrients
Activities of daily living + placebo
Outcomes
Primary Outcome Measures
Endothelium-dependent flow mediated dilation
Secondary Outcome Measures
Biomarkers of endothelial function in blood from umbilical vein and maternal blood
Markers of mitochondrial function
Neonatal and maternal anthropometric indicators
Quality of life SF-12
Functional capacity (VO2max)
Full Information
NCT ID
NCT00872365
First Posted
March 27, 2009
Last Updated
October 10, 2018
Sponsor
Universidad del Valle, Colombia
Collaborators
Fundación FES, Fundación Cardiovascular de Colombia, Instituto Nacional de Salud, University College, London
1. Study Identification
Unique Protocol Identification Number
NCT00872365
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Valle, Colombia
Collaborators
Fundación FES, Fundación Cardiovascular de Colombia, Instituto Nacional de Salud, University College, London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
To evaluate the effect of associated both the maternal and placental metabolic factors to non-transmissible chronic diseases in newborn.
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:
There is correlation between the metabolic factors, related to non-transmissible chronic diseases, of the mother and those of the newborn one.
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.
The simultaneous intervention with micronutrients or physical exercise produces an additional beneficial effect in the metabolic state of the mother and the newborn one.
The metabolic alterations when being born are not exclusive of newborn with anthropometric measures located either in the inferior or superior percentiles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Pregnancy, Micronutrients, Exercise
Keywords
Pregnancy, Exercise, Nutrition, Micronutrients, non-transmissible chronic diseases, Endothelium
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Regular aerobic physical exercise + placebo
Arm Title
2
Arm Type
Other
Arm Description
Activities of daily living + Micronutrients
Arm Title
3
Arm Type
Other
Arm Description
Regular aerobic exercise + micronutrients
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Activities of daily living + placebo
Intervention Type
Behavioral
Intervention Name(s)
Regular aerobic physical exercise
Other Intervention Name(s)
Intervention I
Intervention Description
Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrients
Other Intervention Name(s)
Intervention II
Intervention Description
Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
Intervention Type
Other
Intervention Name(s)
Activities of daily living + placebo
Intervention Description
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care.
Placebo Comparator: Equivalent to placebo (maltodextrin).
Primary Outcome Measure Information:
Title
Endothelium-dependent flow mediated dilation
Time Frame
Baseline / week 32-36 of gestation
Secondary Outcome Measure Information:
Title
Biomarkers of endothelial function in blood from umbilical vein and maternal blood
Time Frame
Baseline / 32-36 weeks gestation and delivery
Title
Markers of mitochondrial function
Time Frame
Baseline / 32-36 weeks gestation and delivery
Title
Neonatal and maternal anthropometric indicators
Time Frame
Baseline / 32-36 weeks gestation and delivery
Title
Quality of life SF-12
Time Frame
Baseline / 32-36 weeks gestation and delivery
Title
Functional capacity (VO2max)
Time Frame
Baseline / 32-36 weeks gestation and delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana C Plata, MSc
Organizational Affiliation
Universidad del Valle, Colombia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julio Cesar Mateus, MD, MEpi
Organizational Affiliation
Fundación FES, División de Salud. Colombia
Official's Role
Study Chair
Facility Information:
Facility Name
Ana C Plata, MSc
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22341377
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.
Results Reference
derived
PubMed Identifier
21356082
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.
Results Reference
derived
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Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
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