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Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Universidad del Valle, Colombia.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Fundación FES
Fundación Cardiovascular de Colombia
Instituto Nacional de Salud
University College, London
Information provided by:
Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00872365
First received: March 27, 2009
Last updated: January 8, 2011
Last verified: January 2011
  Purpose

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.

Condition Intervention Phase
Preeclampsia
Pregnancy
Micronutrients
Exercise
Behavioral: Regular aerobic physical exercise
Dietary Supplement: Micronutrients
Other: Activities of daily living + placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases

Resource links provided by NLM:


Further study details as provided by Universidad del Valle, Colombia:

Primary Outcome Measures:
  • Endothelium-dependent flow mediated dilation [ Time Frame: Baseline / week 32-36 of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers of endothelial function in blood from umbilical vein and maternal blood [ Time Frame: Baseline / 32-36 weeks gestation and delivery ] [ Designated as safety issue: No ]
  • Markers of mitochondrial function [ Time Frame: Baseline / 32-36 weeks gestation and delivery ] [ Designated as safety issue: No ]
  • Neonatal and maternal anthropometric indicators [ Time Frame: Baseline / 32-36 weeks gestation and delivery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline / 32-36 weeks gestation and delivery ] [ Designated as safety issue: No ]
  • Functional capacity (VO2max) [ Time Frame: Baseline / 32-36 weeks gestation and delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: March 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Regular aerobic physical exercise + placebo
Behavioral: Regular aerobic physical exercise
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 Name: Intervention I
2
Activities of daily living + Micronutrients
Dietary Supplement: Micronutrients
Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
Other Name: Intervention II
3
Regular aerobic exercise + micronutrients
Behavioral: Regular aerobic physical exercise
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 Name: Intervention I
Dietary Supplement: Micronutrients
Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
Other Name: Intervention II
Placebo Comparator: 4
Activities of daily living + placebo
Other: 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).


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

Ages Eligible for Study:   16 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872365

Contacts
Contact: Ana C Aguilar, MSc +57 2 5185603 caplata@univalle.edu.co
Contact: Julio Cesar Mateus, MD, Mepi +57 2 6534141 jcmateus@fundacionfes.org

Locations
Colombia
Ana C Plata, MSc Not yet recruiting
Cali, Valle del Cauca, Colombia
Contact: Ana C Plata, MSc    +57 2 5185603    caplata@univalle.edu.co   
Contact: Jullio C Mateus, MD, MSC    +57 2 6534141 ext 113-131    jcmateus@fundacionfes.org   
Sub-Investigator: Patricio Lopez-Jaramillo, MD, PhD         
Sub-Investigator: Robinson Ramirez Velez, FT, PhD (s)         
Sub-Investigator: Salvador Moncada, FRS         
Sponsors and Collaborators
Universidad del Valle, Colombia
Fundación FES
Fundación Cardiovascular de Colombia
Instituto Nacional de Salud
University College, London
Investigators
Study Chair: Ana C Plata, MSc Universidad del Valle, Colombia
Study Chair: Julio Cesar Mateus, MD, MEpi Fundación FES, División de Salud. Colombia
  More Information

No publications provided by Universidad del Valle, Colombia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universidad del Valle, Colombia, Grupo de Nutrición
ClinicalTrials.gov Identifier: NCT00872365     History of Changes
Other Study ID Numbers: Colciencias 110645921540
Study First Received: March 27, 2009
Last Updated: January 8, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad del Valle, Colombia:
Pregnancy
Exercise
Nutrition
Micronutrients
non-transmissible chronic diseases
Endothelium

Additional relevant MeSH terms:
Chronic Disease
Pre-Eclampsia
Disease Attributes
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014