Overweight and ObesitySIMBAIIINCT04377386
Efficacy of Oral Vitamin D Supplementation in Adolescents and Young Adults.
A study testing 1000 IU D vitamin and 200 IU D vitamin in people with Overweight and Obesity and Overweight Adolescents, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
This study assesses whether oral supplementation with vitamin D contributes to the reduction of body mass index and lipid profile in adolescents and young adults. The intervention group will receive 1000 IU of vitamin D (DV) and the control group 200 IU of DV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Overweight Adolescents, Vitamin D Deficiency
- What is being tested?
- 1000 IU D vitamin and 200 IU D vitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- 3 Aug 2020to 2 Feb 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Belonging to the SIMBA cohort.
- Age ≥ 18 years.
- Re-contact consent from previous studies.
Who cannot join
- Medical diagnosis of diabetes mellitus, clinically manifest endocrinopathies, acute or chronic infectious liver disease, and kidney disease.
- Adolescents or Young adults subject to treatment with steroids or hormones (except levothyroxine) up to one month before lab sample taking.
- Current supplementation with VD (any form).
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Cardiovascular de Colombia
Floridablanca, Santander Department, 681004
About this study
Official title: Efficacy of Oral Vitamin D Supplementation in Reducing Body Mass Index and Lipid Profile in Adolescents and Young Adults in Colombia: a Pilot Clinical Trial Protocol Nested in the SIMBA Cohort
This study assesses whether oral supplementation with vitamin D contributes to the reduction of body mass index and lipid profile in adolescents and young adults. The intervention group will receive 1000 IU of vitamin D (DV) and the control group 200 IU of DV.
Read the detailed description
Sample size: the simple size was calculated considering the following parameters: an expected difference in the study outcomes (overweight, obesity, and alteration of the lipid profile) of 20% between the intervention group and the control group; a power of 90%, an alfa of 5%, an intervention group/control group ratio of 1:1, and a 20% adjustment for losses to follow-up, resulting in a sample of 270 participants (n=135 intervention and n=135 control group). The OpenEpi software was used for the calculation. Since this is a pilot study and considering the feasibility, the research team decided on a sample size of 150 participants (n=75 intervention group and n=75 control group).
Randomization and blinding: the randomization process will take place in two stages. An engineer from the data central will conduct the randomization of the list of the 217 potentially eligible participants by means of a computer program with random numbers and it will select 150 individuals to participate in the study. Subsequently, a nurse will make phone calls to schedule appointments and formalize the participation in the study, the signature of the informed consent, and the taking of baseline measures. Once these stages are concluded, the assignment of treatment in real time will be made with the support of a computer program. The procedure will take place by means of a single assignment sequence that determines the assignment code for each participant's treatment.
Supplements will be packaged in individual packages with the total number of doses per participant (105 doses). The coding of the packages will be in charge of the laboratory in charge of providing the supplements, which in turn will send to the designated person at the data center by institutional e-mail, a document with the list of codes and the dose of the supplement. The 1000 IU and 200 IU doses of VD will be provided in white containers and will be identical in terms of physical and organoleptic characteristics, to ensure that both participants and investigators are blinded to the treatment. To maximize adherence to the intervention, participants will be required to cross out daily supplementation on a calendar with the study period, which participants should return at the end of the study.
The results of the assignment will only be known by the systems engineer at the data center. In other words, this information "will not be visible" to the coordinating nurse, laboratory personnel in charge of processing biological samples, pediatrician, principal investigator of the study, or the epidemiologist in charge of quality control and data analysis. This will ensure the masking of the people in charge of measuring the outcomes, administering the intervention and analyzing the study data.
Recruitment: for recruitment, a study nurse in charge of enrollment will contact by phone the 217 successful participants of the third re-contact, explain the objective of the study and inquire about the interest to participate; if there is a positive response, inclusion and exclusion criteria will be verified. A list of eligible participants will be generated from the above process and sent to the person in charge of the randomization process.
After the randomization process, the study nurse will receive from the data center the list of the 150 participants selected, who will be invited to participate in the clinical trial. The nurse will call them on the pone for a face-to-face appointment where the details of the study will be informed, doubts will be clarified, and the informed consent form will be signed; a copy of the form will be given to the participant.
During that appointment, the collection of demographic and clinical data will take place, as well as a blood simple for further measurement of VD, lipid profile and glycaemia; The anthropometric nutritional, dietary and physical activity assessment will also be carried out. Once the baseline measurements are taken, the assignment to the intervention will be made in real time through software designed for the study.
Finally, the supplementation intervention will be explained in detail and the package corresponding to the participant's code will be delivered according to the process of assignment to the group (intervention/control), it will be clarified that the supplementation will last 15 weeks and then the second meeting will be scheduled to carry out again the measures taken at the beginning of the study. At the end, a third meeting will be scheduled for the delivery of results and recommendations.
Ethical considerations: the research will be carried out following the principles established in the Good Clinical Practice in Clinical Trials GPC/ICH. It is considered a minimum risk study according to resolution 008430 of October 4, 1993 of the Colombian Ministry of Health, since it includes the administration of a commonly used vitamin supplement with a wide therapeutic margin and for its administration the indications, doses and routes of administration established by the Institute for Drug and Food Surveillance (Invima, acronym in Spanish) are considered.
The vitamin supplement is supplied by the laboratory Farma de Colombia, commercially known as Farma D, whose presentation is in soft gelatin capsules and with registration number 2017 M-0012231-R1.
The processing of personal and clinical data and biological samples will be handled according to the Habeas Data Act (Act 1266 of 2008) of the government of Colombia.
The study was reviewed and endorsed by the Technical Scientific Committee (CTC) of Fundacion Cardiovascular de Colombia (FCV) according to minute N°133 of May 2018 and has the approval of the Research Ethics Committee (IEC) of the FCV according to minute N°480 of July 16, 2019.
The study nurse will explain the objectives, importance, risks, benefits of the research and the confidentiality of the data. Written informed consent will be given to study participants.
Statistical analysis : an analysis will be made by intention to treat. The description of the categorical variables will be made by means of absolute and relative values. Quantitative variables that present a normal distribution in Shapiro Wilk's test will be reported as mean and standard deviation, otherwise the median and interquartile range will be presented. The comparison of the basal characteristics of the study groups (intervention and control) will be done using the ratio comparison test (Chi-square or Fischer's exact test) and the Student's t-test or Mann-Whitney's U-test.
Quantitative outcome variables will be contrasted through paired t-tests or Wilcoxon tests for quantitative variables, methods of longitudinal data analysis will also be explored and for categorical ones the Mc Nemar test will be used. Statistical significance will be considered for all hypothesis tests when the p value is less than 0.05.
- Being tested
- 1000 IU D vitamin, 200 IU D vitamin
- Keywords
- Vitamin D, Obesity, Weight loss, Body composition, Cholesterol, Triglycerides
- Medical subject headings
- Overweight, Obesity, Vitamin D Deficiency, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1000 IU D vitaminDietary supplement
Also called Supplementation with 1000 IU vitamin D, Farma D 1000 IU
Participants in the intervention group will receive 105 DV doses of 1000 IU. The supplementation will be given by the Farma de Colombia laboratory, known commercially as Farma D, whose presentation is in soft gelatin capsules. It is recommended to take one dose per day at the same time and participants should record the daily intake time of the supplement for 15 weeks on a calendar.
200 IU D vitaminDietary supplement
Also called Supplementation with 200 IU vitamin D, Farma D 200 IU
Participants in the control group will receive 105 DV doses of 200 IU. The supplementation will be given by the same laboratory; it will have the same characteristics and recommendations for the intake as for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: 1000 IU DV | Experimental | The 75 participants assigned to the intervention group will take 1 DV capsule of 1000 IU daily for 15 weeks. Receives: Dietary Supplement: 1000 IU D vitamin |
| Control group: 200 IU DV | Placebo comparator | The 75 participants of the control group will take 1 DV capsule of 200 IU daily for 15 weeks, this dose being the minimum recommended for children. The above, considering that it is ethical for the control group to receive a minimum dose of supplementation. Receives: Dietary Supplement: 200 IU D vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index between baseline and week 15
Change in body mass index (BMI) will be made through of the measure of body weight will be in kilograms (kg) to one decimal place, and the size in meters (m) to two decimal places. From these measurements the body mass index will be obtained using the formula: BMI = Weight (kg) / size (m)2.
Measured: Baseline and week 15
Change in lipid profile (Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides) between baseline and week 15
Serum is measured from the same blood samples drawn for vitamin D levels. The processing and analysis of the samples will be done respectively through enzymatic technique, selective liquid detergent, selective detergent accelerator and Glycerol Phosphate Oxidase.
Measured: Baseline and week 15
Change in 25-hydroxyvitamin D [25(OH)D] levels between baseline and week 15
After a 10-12 hour fast, in peripheral venous blood 25-hydroxyvitamin D [25(OH)D] is quantified in serum by chemiluminescent microparticle immunoassay (CMIA).
Measured: baseline and week 15
Secondary outcomes (3)
Change in waist - hip ratio between baseline and week 15
Determines the intra-abdominal fat levels and is obtained by dividing the waist perimeter by the hip perimeter. The circumference of the waist shall be measured at the midpoint between the edge of the lower sack (10th rib) and the upper edge of the iliac crest, without adjusting or stopping touching the skin.
For the measurement of the hip, the knees and the heels must be together; the most prominent part of the hip on both sides shall be located and the tape measure shall be passed following the same recommendations as for the circumference of the waist.
Measured: Baseline and week 15
Change of percentage body fat (PBF) in skin folds between baseline and week 15
These are taken for the indirect estimation by means of measuring the bicipital, tricipital, abdominal, and subscapular folds. These measurements will be taken using a Harpender® skinfold caliper. Percentage of body fat (%BF) calculated with the Siri equation for four skin folds (SF), like so: % BF SIRI = ((4.95 / D) - 4.5) x 100. Body density (D) is obtained using the linear regression equation proposed by Durnin and Womersley (C and D). D = C - M x log10 ∑ 4SF (bicipital, tricipital, abdominal, and subscapular).
Measured: Baseline and week 15
Change in fasting blood glucose level between baseline and week 15
After a 10-12 hour fast, blood glucose levels are measured in serum from the same blood samples drawn for vitamin D levels, using the hexokinase/G-6-PDH technique.
Measured: Baseline and week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start3 Aug 2020
- Primary completion2 Nov 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study of a two-arm, triple-blind, parallel randomized controlled clinical trial, in 150 adolescents and young adults in the city of Bucaramanga-Colombia. All participants will be given 105 doses of VD. The 75 participants assigned to the intervention group will take one 1000 IU VD capsule daily for 15 weeks. On the other hand, the 75 participants in the control group will take 1 capsule of VD of 200 IU for the same time. The participants in both the intervention and the control group must record in a calendar the time of the daily intake of the supplement during the 15 weeks. The main outcomes are: serum levels of 25 (OH) D, body mass index and lipid profile; Secondary measures complement the previous ones (skin folds, waist-to-hip ratio). Other variables will be analyzed such as: assessment of dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and adherence to supplementation with DV.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Industrial de Santander, Farma de Colombia SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377386
- Sponsor's protocol ID
- ECA-SIMBA-III-2020
- Other IDs
- 656680763838, 2020-03-71, 133-052018
- Acronym
- SIMBAIII
- Status last verified
- Jan 2024
- First submitted
- 7 Apr 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charoenngam N, Shirvani A, Holick MF. Vitamin D for skeletal and non-skeletal health: What we should know. J Clin Orthop Trauma. 2019 Nov-Dec;10(6):1082-1093. doi: 10.1016/j.jcot.2019.07.004. Epub 2019 Jul 13.
PubMed 31708633Al Mheid I, Quyyumi AA. Vitamin D and Cardiovascular Disease: Controversy Unresolved. J Am Coll Cardiol. 2017 Jul 4;70(1):89-100. doi: 10.1016/j.jacc.2017.05.031.
PubMed 28662812Gholami F, Moradi G, Zareei B, Rasouli MA, Nikkhoo B, Roshani D, Ghaderi E. The association between circulating 25-hydroxyvitamin D and cardiovascular diseases: a meta-analysis of prospective cohort studies. BMC Cardiovasc Disord. 2019 Nov 7;19(1):248. doi: 10.1186/s12872-019-1236-7.
PubMed 31699030Paschou SA, Kosmopoulos M, Nikas IP, Spartalis M, Kassi E, Goulis DG, Lambrinoudaki I, Siasos G. The Impact of Obesity on the Association between Vitamin D Deficiency and Cardiovascular Disease. Nutrients. 2019 Oct 14;11(10):2458. doi: 10.3390/nu11102458.
PubMed 31615154Alloubani A, Akhu-Zaheya L, Samara R, Abdulhafiz I, Saleh A, Altowijri A. Relationship between Vitamin D Deficiency, Diabetes, and Obesity. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1457-1461. doi: 10.1016/j.dsx.2019.02.021. Epub 2019 Feb 20.
PubMed 31336506Hossain MJ, Levinson A, George D, Canas J, Kumar S, Balagopal PB. Vitamin D Status and Cardiovascular Risk in Obesity: Effect of Physical Activity in Nonvitamin D Supplemented Adolescents. Metab Syndr Relat Disord. 2018 May;16(4):197-203. doi: 10.1089/met.2017.0171. Epub 2018 Mar 13.
PubMed 29649377Zakharova I, Klimov L, Kuryaninova V, Nikitina I, Malyavskaya S, Dolbnya S, Kasyanova A, Atanesyan R, Stoyan M, Todieva A, Kostrova G, Lebedev A. Vitamin D Insufficiency in Overweight and Obese Children and Adolescents. Front Endocrinol (Lausanne). 2019 Mar 1;10:103. doi: 10.3389/fendo.2019.00103. eCollection 2019.
PubMed 30881343Villa-Roel C, Buitrago A, Rodriguez DC, Cano DJ, Martinez MP, Camacho PA, Ruiz AJ, Duran AE. Prevalence of metabolic syndrome in scholars from Bucaramanga, Colombia: a population-based study. BMC Pediatr. 2009 Apr 21;9:28. doi: 10.1186/1471-2431-9-28.
PubMed 19383169Mueller NT, Pereira MA, Buitrago-Lopez A, Rodriguez DC, Duran AE, Ruiz AJ, Rueda-Clausen CF, Villa-Roel C. Adiposity indices in the prediction of insulin resistance in prepubertal Colombian children. Public Health Nutr. 2013 Feb;16(2):248-55. doi: 10.1017/S136898001200393X. Epub 2012 Aug 24.
PubMed 22916737Serrano N, Villa-Roel C, Gamboa-Delgado EM, Barrera JG, Quintero-Lesmes DC. Early evaluation of the metabolic syndrome in Bucaramanga, Colombia. Transl Pediatr. 2019 Dec;8(5):363-370. doi: 10.21037/tp.2019.04.04.
PubMed 31993348Serrano NC, Rojas LZ, Gamboa-Delgado EM, Suarez DP, Salazar Acosta I, Romero SL, Forero M, Quintero-Lesmes DC. Efficacy of vitamin D supplementation in reducing body mass index and lipid profile in healthy young adults in Colombia: a pilot randomised controlled clinical trial. J Nutr Sci. 2023 Feb 22;12:e29. doi: 10.1017/jns.2022.108. eCollection 2023.
PubMed 36843975Serrano NC, Romero SL, Suarez DP, Rojas LZ, Gamboa-Delgado EM, Forero M, Guio E, Quintero-Lesmes DC. Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia: A pilot clinical trial protocol nested in the SIMBA cohort. Medicine (Baltimore). 2020 Aug 28;99(35):e21722. doi: 10.1097/MD.0000000000021722.
PubMed 32871891
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Vitamin D Supplementation in Reducing Body Mass Index and Lipid Profile in Adolescents and Young Adults in Colombia: a Pilot Clinical Trial Protocol Nested in the SIMBA Cohort
- ClinicalTrials.gov ID
- NCT04377386
- Acronym / sponsor ID
- SIMBAIII / ECA-SIMBA-III-2020
- Keywords
- Vitamin D, Obesity, Weight loss, Body composition, Cholesterol, Triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Collaborators
- Universidad Industrial de Santander, Farma de Colombia SA
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 6 May 2020 (actual)
- 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.
This study assesses whether oral supplementation with vitamin D contributes to the reduction of body mass index and lipid profile in adolescents and young adults. The intervention group will receive 1000 IU of vitamin D (DV) and the control group 200 IU of DV.
Detailed description
Sample size: the simple size was calculated considering the following parameters: an expected difference in the study outcomes (overweight, obesity, and alteration of the lipid profile) of 20% between the intervention group and the control group; a power of 90%, an alfa of 5%, an intervention group/control group ratio of 1:1, and a 20% adjustment for losses to follow-up, resulting in a sample of 270 participants (n=135 intervention and n=135 control group). The OpenEpi software was used for the calculation. Since this is a pilot study and considering the feasibility, the research team decided on a sample size of 150 participants (n=75 intervention group and n=75 control group).
Randomization and blinding: the randomization process will take place in two stages. An engineer from the data central will conduct the randomization of the list of the 217 potentially eligible participants by means of a computer program with random numbers and it will select 150 individuals to participate in the study. Subsequently, a nurse will make phone calls to schedule appointments and formalize the participation in the study, the signature of the informed consent, and the taking of baseline measures. Once these stages are concluded, the assignment of treatment in real time will be made with the support of a computer program. The procedure will take place by means of a single assignment sequence that determines the assignment code for each participant's treatment.
Supplements will be packaged in individual packages with the total number of doses per participant (105 doses). The coding of the packages will be in charge of the laboratory in charge of providing the supplements, which in turn will send to the designated person at the data center by institutional e-mail, a document with the list of codes and the dose of the supplement. The 1000 IU and 200 IU doses of VD will be provided in white containers and will be identical in terms of physical and organoleptic characteristics, to ensure that both participants and investigators are blinded to the treatment. To maximize adherence to the intervention, participants will be required to cross out daily supplementation on a calendar with the study period, which participants should return at the end of the study.
The results of the assignment will only be known by the systems engineer at the data center. In other words, this information "will not be visible" to the coordinating nurse, laboratory personnel in charge of processing biological samples, pediatrician, principal investigator of the study, or the epidemiologist in charge of quality control and data analysis. This will ensure the masking of the people in charge of measuring the outcomes, administering the intervention and analyzing the study data.
Recruitment: for recruitment, a study nurse in charge of enrollment will contact by phone the 217 successful participants of the third re-contact, explain the objective of the study and inquire about the interest to participate; if there is a positive response, inclusion and exclusion criteria will be verified. A list of eligible participants will be generated from the above process and sent to the person in charge of the randomization process.
After the randomization process, the study nurse will receive from the data center the list of the 150 participants selected, who will be invited to participate in the clinical trial. The nurse will call them on the pone for a face-to-face appointment where the details of the study will be informed, doubts will be clarified, and the informed consent form will be signed; a copy of the form will be given to the participant.
During that appointment, the collection of demographic and clinical data will take place, as well as a blood simple for further measurement of VD, lipid profile and glycaemia; The anthropometric nutritional, dietary and physical activity assessment will also be carried out. Once the baseline measurements are taken, the assignment to the intervention will be made in real time through software designed for the study.
Finally, the supplementation intervention will be explained in detail and the package corresponding to the participant's code will be delivered according to the process of assignment to the group (intervention/control), it will be clarified that the supplementation will last 15 weeks and then the second meeting will be scheduled to carry out again the measures taken at the beginning of the study. At the end, a third meeting will be scheduled for the delivery of results and recommendations.
Ethical considerations: the research will be carried out following the principles established in the Good Clinical Practice in Clinical Trials GPC/ICH. It is considered a minimum risk study according to resolution 008430 of October 4, 1993 of the Colombian Ministry of Health, since it includes the administration of a commonly used vitamin supplement with a wide therapeutic margin and for its administration the indications, doses and routes of administration established by the Institute for Drug and Food Surveillance (Invima, acronym in Spanish) are considered.
The vitamin supplement is supplied by the laboratory Farma de Colombia, commercially known as Farma D, whose presentation is in soft gelatin capsules and with registration number 2017 M-0012231-R1.
The processing of personal and clinical data and biological samples will be handled according to the Habeas Data Act (Act 1266 of 2008) of the government of Colombia.
The study was reviewed and endorsed by the Technical Scientific Committee (CTC) of Fundacion Cardiovascular de Colombia (FCV) according to minute N°133 of May 2018 and has the approval of the Research Ethics Committee (IEC) of the FCV according to minute N°480 of July 16, 2019.
The study nurse will explain the objectives, importance, risks, benefits of the research and the confidentiality of the data. Written informed consent will be given to study participants.
Statistical analysis : an analysis will be made by intention to treat. The description of the categorical variables will be made by means of absolute and relative values. Quantitative variables that present a normal distribution in Shapiro Wilk's test will be reported as mean and standard deviation, otherwise the median and interquartile range will be presented. The comparison of the basal characteristics of the study groups (intervention and control) will be done using the ratio comparison test (Chi-square or Fischer's exact test) and the Student's t-test or Mann-Whitney's U-test.
Quantitative outcome variables will be contrasted through paired t-tests or Wilcoxon tests for quantitative variables, methods of longitudinal data analysis will also be explored and for categorical ones the Mc Nemar test will be used. Statistical significance will be considered for all hypothesis tests when the p value is less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study of a two-arm, triple-blind, parallel randomized controlled clinical trial, in 150 adolescents and young adults in the city of Bucaramanga-Colombia. All participants will be given 105 doses of VD. The 75 participants assigned to the intervention group will take one 1000 IU VD capsule daily for 15 weeks. On the other hand, the 75 participants in the control group will take 1 capsule of VD of 200 IU for the same time. The participants in both the intervention and the control group must record in a calendar the time of the daily intake of the supplement during the 15 weeks. The main outcomes are: serum levels of 25 (OH) D, body mass index and lipid profile; Secondary measures complement the previous ones (skin folds, waist-to-hip ratio). Other variables will be analyzed such as: assessment of dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and adherence to supplementation with DV.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: 1000 IU DV | Experimental | Dietary Supplement: 1000 IU D vitaminThe 75 participants assigned to the intervention group will take 1 DV capsule of 1000 IU daily for 15 weeks. |
| Control group: 200 IU DV | Placebo comparator | Dietary Supplement: 200 IU D vitaminThe 75 participants of the control group will take 1 DV capsule of 200 IU daily for 15 weeks, this dose being the minimum recommended for children. The above, considering that it is ethical for the control group to receive a minimum dose of supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Belonging to the SIMBA cohort.
- Age ≥ 18 years.
- Re-contact consent from previous studies.
Key exclusion criteria (3 listed)
- Medical diagnosis of diabetes mellitus, clinically manifest endocrinopathies, acute or chronic infectious liver disease, and kidney disease.
- Adolescents or Young adults subject to treatment with steroids or hormones (except levothyroxine) up to one month before lab sample taking.
- Current supplementation with VD (any form).
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 |
|---|---|---|
| 1000 IU D vitaminAlso: Supplementation with 1000 IU vitamin D, Farma D 1000 IUParticipants in the intervention group will receive 105 DV doses of 1000 IU. The supplementation will be given by the Farma de Colombia laboratory, known commercially as Farma D, whose presentation is in soft gelatin capsules. It is recommended to take one dose per day at the same time and participants should record the daily intake time of the supplement for 15 weeks on a calendar. | Dietary supplement | Intervention group: 1000 IU DV |
| 200 IU D vitaminAlso: Supplementation with 200 IU vitamin D, Farma D 200 IUParticipants in the control group will receive 105 DV doses of 200 IU. The supplementation will be given by the same laboratory; it will have the same characteristics and recommendations for the intake as for the intervention group. | Dietary supplement | Control group: 200 IU DV |
Primary outcome
Change in body mass index between baseline and week 15
Time frame: Baseline and week 15
Change in body mass index (BMI) will be made through of the measure of body weight will be in kilograms (kg) to one decimal place, and the size in meters (m) to two decimal places. From these measurements the body mass index will be obtained using the formula: BMI = Weight (kg) / size (m)2.
Change in lipid profile (Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides) between baseline and week 15
Time frame: Baseline and week 15
Serum is measured from the same blood samples drawn for vitamin D levels. The processing and analysis of the samples will be done respectively through enzymatic technique, selective liquid detergent, selective detergent accelerator and Glycerol Phosphate Oxidase.
Change in 25-hydroxyvitamin D [25(OH)D] levels between baseline and week 15
Time frame: baseline and week 15
After a 10-12 hour fast, in peripheral venous blood 25-hydroxyvitamin D [25(OH)D] is quantified in serum by chemiluminescent microparticle immunoassay (CMIA).
3 secondary outcomes
Change in waist - hip ratio between baseline and week 15
Time frame: Baseline and week 15
Change of percentage body fat (PBF) in skin folds between baseline and week 15
Time frame: Baseline and week 15
Change in fasting blood glucose level between baseline and week 15
Time frame: Baseline and week 15
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 1 Feb 2024.
- Background: PubMed 31708633Charoenngam N, Shirvani A, Holick MF. Vitamin D for skeletal and non-skeletal health: What we should know. J Clin Orthop Trauma. 2019 Nov-Dec;10(6):1082-1093. doi: 10.1016/j.jcot.2019.07.004. Epub 2019 Jul 13.
- Background: PubMed 28662812Al Mheid I, Quyyumi AA. Vitamin D and Cardiovascular Disease: Controversy Unresolved. J Am Coll Cardiol. 2017 Jul 4;70(1):89-100. doi: 10.1016/j.jacc.2017.05.031.
- Background: PubMed 31699030Gholami F, Moradi G, Zareei B, Rasouli MA, Nikkhoo B, Roshani D, Ghaderi E. The association between circulating 25-hydroxyvitamin D and cardiovascular diseases: a meta-analysis of prospective cohort studies. BMC Cardiovasc Disord. 2019 Nov 7;19(1):248. doi: 10.1186/s12872-019-1236-7.
- Background: PubMed 31615154Paschou SA, Kosmopoulos M, Nikas IP, Spartalis M, Kassi E, Goulis DG, Lambrinoudaki I, Siasos G. The Impact of Obesity on the Association between Vitamin D Deficiency and Cardiovascular Disease. Nutrients. 2019 Oct 14;11(10):2458. doi: 10.3390/nu11102458.
- Background: PubMed 31336506Alloubani A, Akhu-Zaheya L, Samara R, Abdulhafiz I, Saleh A, Altowijri A. Relationship between Vitamin D Deficiency, Diabetes, and Obesity. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1457-1461. doi: 10.1016/j.dsx.2019.02.021. Epub 2019 Feb 20.
- Background: PubMed 29649377Hossain MJ, Levinson A, George D, Canas J, Kumar S, Balagopal PB. Vitamin D Status and Cardiovascular Risk in Obesity: Effect of Physical Activity in Nonvitamin D Supplemented Adolescents. Metab Syndr Relat Disord. 2018 May;16(4):197-203. doi: 10.1089/met.2017.0171. Epub 2018 Mar 13.
- Background: PubMed 30881343Zakharova I, Klimov L, Kuryaninova V, Nikitina I, Malyavskaya S, Dolbnya S, Kasyanova A, Atanesyan R, Stoyan M, Todieva A, Kostrova G, Lebedev A. Vitamin D Insufficiency in Overweight and Obese Children and Adolescents. Front Endocrinol (Lausanne). 2019 Mar 1;10:103. doi: 10.3389/fendo.2019.00103. eCollection 2019.
- Background: PubMed 19383169Villa-Roel C, Buitrago A, Rodriguez DC, Cano DJ, Martinez MP, Camacho PA, Ruiz AJ, Duran AE. Prevalence of metabolic syndrome in scholars from Bucaramanga, Colombia: a population-based study. BMC Pediatr. 2009 Apr 21;9:28. doi: 10.1186/1471-2431-9-28.
- Background: PubMed 22916737Mueller NT, Pereira MA, Buitrago-Lopez A, Rodriguez DC, Duran AE, Ruiz AJ, Rueda-Clausen CF, Villa-Roel C. Adiposity indices in the prediction of insulin resistance in prepubertal Colombian children. Public Health Nutr. 2013 Feb;16(2):248-55. doi: 10.1017/S136898001200393X. Epub 2012 Aug 24.
- Background: PubMed 31993348Serrano N, Villa-Roel C, Gamboa-Delgado EM, Barrera JG, Quintero-Lesmes DC. Early evaluation of the metabolic syndrome in Bucaramanga, Colombia. Transl Pediatr. 2019 Dec;8(5):363-370. doi: 10.21037/tp.2019.04.04.
- Derived from this study: PubMed 36843975Serrano NC, Rojas LZ, Gamboa-Delgado EM, Suarez DP, Salazar Acosta I, Romero SL, Forero M, Quintero-Lesmes DC. Efficacy of vitamin D supplementation in reducing body mass index and lipid profile in healthy young adults in Colombia: a pilot randomised controlled clinical trial. J Nutr Sci. 2023 Feb 22;12:e29. doi: 10.1017/jns.2022.108. eCollection 2023.
- Derived from this study: PubMed 32871891Serrano NC, Romero SL, Suarez DP, Rojas LZ, Gamboa-Delgado EM, Forero M, Guio E, Quintero-Lesmes DC. Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia: A pilot clinical trial protocol nested in the SIMBA cohort. Medicine (Baltimore). 2020 Aug 28;99(35):e21722. doi: 10.1097/MD.0000000000021722.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1000 IU D vitamin and 200 IU D vitamin in people with Overweight and Obesity and Overweight Adolescents, run by Fundación Cardiovascular de 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 3 inclusion and 3 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 1 Feb 2024. 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?
Change in body mass index between baseline and week 15 (time frame: Baseline and week 15). The study lists 3 primary outcomes in all. 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 NCT04377386, which also lists 12 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 1 Feb 2024.