PreeclampsiaNCT00872365
Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
A study testing Regular aerobic physical exercise and Micronutrients in people with Preeclampsia and Pregnancy, run by Universidad del Valle, Colombia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Pregnancy, Micronutrients
- What is being tested?
- Regular aerobic physical exercise and Micronutrients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Preeclampsia, Pregnancy, Micronutrients, Exercise
- Being tested
- Regular aerobic physical exercise, Micronutrients, Activities of daily living + placebo
- Keywords
- Pregnancy, Exercise, Nutrition, Micronutrients, non-transmissible chronic diseases, Endothelium
- Medical subject headings
- Pre-Eclampsia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular aerobic physical exerciseBehavioural
Also called Intervention I
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.
MicronutrientsDietary supplement
Also called Intervention II
Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
Activities of daily living + placeboOther
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care.
Placebo Comparator: Equivalent to placebo (maltodextrin).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Regular aerobic physical exercise + placebo Receives: Behavioral: Regular aerobic physical exercise |
| 2 | Other | Activities of daily living + Micronutrients Receives: Dietary Supplement: Micronutrients |
| 3 | Other | Regular aerobic exercise + micronutrients Receives: Behavioral: Regular aerobic physical exercise; Dietary Supplement: Micronutrients |
| 4 | Placebo comparator | Activities of daily living + placebo Receives: Other: Activities of daily living + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent flow mediated dilation
Measured: Baseline / week 32-36 of gestation
Secondary outcomes (5)
Biomarkers of endothelial function in blood from umbilical vein and maternal blood
Measured: Baseline / 32-36 weeks gestation and delivery
Markers of mitochondrial function
Measured: Baseline / 32-36 weeks gestation and delivery
Neonatal and maternal anthropometric indicators
Measured: Baseline / 32-36 weeks gestation and delivery
Quality of life SF-12
Measured: Baseline / 32-36 weeks gestation and delivery
Functional capacity (VO2max)
Measured: Baseline / 32-36 weeks gestation and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle, Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FES, Fundación Cardiovascular de Colombia, Instituto Nacional de Salud, University College, London
- Responsible party
- Principal investigator, Robinsón Ramírez, Universidad del Valle, Colombia
- Investigators
- Ana C Plata, MSc, Study chair, Universidad del Valle, ColombiaJulio Cesar Mateus, MD, MEpi, Study chair, Fundación FES, División de Salud. Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872365
- Sponsor's protocol ID
- Colciencias 110645921540
- Status last verified
- Oct 2018
- First submitted
- 27 Mar 2009
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22341377Ramirez-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.
PubMed 21356082
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases
- ClinicalTrials.gov ID
- NCT00872365
- Acronym / sponsor ID
- Colciencias 110645921540
- Conditions
- Preeclampsia, Pregnancy, Micronutrients, Exercise
- Keywords
- Pregnancy, Exercise, Nutrition, Micronutrients, non-transmissible chronic diseases, Endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Universidad del Valle, ColombiaUniversity, hospital or other
- Collaborators
- Fundación FES, Fundación Cardiovascular de Colombia, Instituto Nacional de Salud, University College, London
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Regular aerobic physical exerciseRegular aerobic physical exercise + placebo |
| 2 | Other | Dietary Supplement: MicronutrientsActivities of daily living + Micronutrients |
| 3 | Other | Behavioral: Regular aerobic physical exercise, Dietary Supplement: MicronutrientsRegular aerobic exercise + micronutrients |
| 4 | Placebo comparator | Other: Activities of daily living + placeboActivities of daily living + placebo |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular aerobic physical exerciseAlso: Intervention IWalking (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. | Behavioural | 1, 3 |
| MicronutrientsAlso: Intervention IIZinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg. | Dietary supplement | 2, 3 |
| Activities of daily living + placeboBasic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care. Placebo Comparator: Equivalent to placebo (maltodextrin). | Other | 4 |
Primary outcome
Endothelium-dependent flow mediated dilation
Time frame: Baseline / week 32-36 of gestation
5 secondary outcomes
Biomarkers of endothelial function in blood from umbilical vein and maternal blood
Time frame: Baseline / 32-36 weeks gestation and delivery
Markers of mitochondrial function
Time frame: Baseline / 32-36 weeks gestation and delivery
Neonatal and maternal anthropometric indicators
Time frame: Baseline / 32-36 weeks gestation and delivery
Quality of life SF-12
Time frame: Baseline / 32-36 weeks gestation and delivery
Functional capacity (VO2max)
Time frame: Baseline / 32-36 weeks gestation and delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 22341377Robledo-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.
- Derived from this study: PubMed 21356082Ramirez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana C Plata, MSc study chair
Universidad del Valle, Colombia
Julio Cesar Mateus, MD, MEpi study chair
Fundación FES, División de Salud. Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular aerobic physical exercise and Micronutrients in people with Preeclampsia and Pregnancy, run by Universidad del Valle, Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelium-dependent flow mediated dilation (time frame: Baseline / week 32-36 of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00872365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.