- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872365
Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valle Del Cauca
-
Cali, Valle Del Cauca, Colombia
- Ana C Plata, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Regular aerobic physical exercise + placebo
|
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.
Other Names:
|
Other: 2
Activities of daily living + Micronutrients
|
Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
Other Names:
|
Other: 3
Regular aerobic exercise + micronutrients
|
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.
Other Names:
Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
Other Names:
|
Placebo Comparator: 4
Activities of daily living + placebo
|
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care. Placebo Comparator: Equivalent to placebo (maltodextrin). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelium-dependent flow mediated dilation
Time Frame: Baseline / week 32-36 of gestation
|
Baseline / week 32-36 of gestation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biomarkers of endothelial function in blood from umbilical vein and maternal blood
Time Frame: Baseline / 32-36 weeks gestation and delivery
|
Baseline / 32-36 weeks gestation and delivery
|
Markers of mitochondrial function
Time Frame: Baseline / 32-36 weeks gestation and delivery
|
Baseline / 32-36 weeks gestation and delivery
|
Neonatal and maternal anthropometric indicators
Time Frame: Baseline / 32-36 weeks gestation and delivery
|
Baseline / 32-36 weeks gestation and delivery
|
Quality of life SF-12
Time Frame: Baseline / 32-36 weeks gestation and delivery
|
Baseline / 32-36 weeks gestation and delivery
|
Functional capacity (VO2max)
Time Frame: Baseline / 32-36 weeks gestation and delivery
|
Baseline / 32-36 weeks gestation and delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ana C Plata, MSc, Universidad del Valle, Colombia
- Study Chair: Julio Cesar Mateus, MD, MEpi, Fundación FES, División de Salud. Colombia
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Colciencias 110645921540
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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