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

NCT ID: NCT00872365

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Preeclampsia; Pregnancy; Micronutrients; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Regular aerobic physical exercise + placebo

Group Type: OTHER

Regular aerobic physical exercise

Intervention Type: BEHAVIORAL

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.

2

Activities of daily living + Micronutrients

Group Type: OTHER

Micronutrients

Intervention Type: DIETARY_SUPPLEMENT

Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.

3

Regular aerobic exercise + micronutrients

Group Type: OTHER

Regular aerobic physical exercise

Intervention Type: BEHAVIORAL

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.

Micronutrients

Intervention Type: DIETARY_SUPPLEMENT

Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.

4

Activities of daily living + placebo

Group Type: PLACEBO_COMPARATOR

Activities of daily living + placebo

Intervention Type: OTHER

Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care.

Placebo Comparator: Equivalent to placebo (maltodextrin).

Interventions

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.

Intervention Type: BEHAVIORAL

Micronutrients

Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: OTHER

Other Intervention Names

Intervention I; Intervention II

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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación FES

OTHER

Sponsor Role: collaborator

Fundación Cardiovascular de Colombia

OTHER

Sponsor Role: collaborator

Instituto Nacional de Salud

UNKNOWN

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Universidad del Valle, Colombia

OTHER

Sponsor Role: lead

Responsible Party

Robinsón Ramírez

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julio Cesar Mateus, MD, MEpi

Role: STUDY_CHAIR

Fundación FES, División de Salud. Colombia

Ana C Plata, MSc

Role: STUDY_CHAIR

Universidad del Valle, Colombia

Locations

Ana C Plata, MSc

Cali, Valle del Cauca Department, Colombia

Countries

Colombia

References

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.

Reference Type: DERIVED

PMID: 22341377 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21356082 (View on PubMed)

Other Identifiers

Colciencias 110645921540

Identifier Type: -

Identifier Source: org_study_id