Malnutrition, ChildNCT03355313
Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition
A study testing Low level Light therapy in people with Malnutrition, Child, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
Malnutrition is a clinical-social disease caused by multiple prenatal, intrauterine and postnatal factors as well as social, political and cultural determinants (distal causes). Despite the global and national reductions in the number of cases, malnutrition continues to be a public health problem, with greater… Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Low level Light therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2017to 30 Jul 2018
- 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 12 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged one to five years enrolled at the Center for Educational and Nutrition Recovery in the city of Maceió whose parent/guardians signed as statement of informed consent agreeing to the participation of the children.
- Children suffering of malnutrition.
Who cannot join
- Children aged one to five years not enrolled at the Center for Educational and Nutrition Recovery in the city of Maceió and children whose parents/guardians did not sign a statement of informed consent.
- Children not suffering of malnutrition.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Centro de Educação e Recuperação Nutricional
Maceió, Alagoas, 57000000
University of Nove de Julho
São Paulo, 01504000
About this study
Malnutrition is a clinical-social disease caused by multiple prenatal, intrauterine and postnatal factors as well as social, political and cultural determinants (distal causes). Despite the global and national reductions in the number of cases, malnutrition continues to be a public health problem, with greater prevalence in pockets of poverty found in the northern and northeastern regions of Brazil.
Episodes of malnutrition in early childhood, with consequent calcium, phosphate and vitamin A, C and D deficiencies, can increase one's susceptibility to dental caries through three probable mechanisms: defects in tooth formation (odontogenesis), delayed tooth eruption and alterations in the salivary glands.
Read more
It is likely that the significant increase in susceptibility to caries in malnourished individuals stems from alterations in the salivary secretion rate, since a reduction in salivary flow (salivary gland atrophy) increases the susceptibility to both dental caries and dental erosion. As saliva is the main defense factor of the oral cavity, a reduction/change in its physical properties (secretion rate and buffering capacity) can cause immunological disorders that affect an individual's defense capacity.
Studies have demonstrated that salivary immunoglobulin A (IgA) also plays an important role in the immunity of the oral mucosa. Indeed, patients with IgA deficiency can experience recurring upper airway (tonsillitis, ear infection and sinusitis), lower airway (pneumonia) and gastrointestinal (diarrhea and parasitosis) infections.
The investigation of mechanisms that can reduce the impact of malnutrition on the defenses of the organism is of the utmost important and interest to public health. Among such mechanisms, low-level laser therapy has demonstrated effectiveness in the treatment of diverse conditions and disease through the promotion of the biomodulation of the cell metabolism and due to its analgesic and anti-inflammatory properties with no mutagenic or photothermal effects.
Read the detailed description
Laser stimulation of the major salivary glands to produce more saliva occurs through the increase in local circulation due to vasodilatation, the induction of the proliferation of glandular cells and cell respiration/ATP (adenosine triphosphate) synthesis as well as the release of growth factors and cytokines to stimulate protein exocytosis. With regard to an increase in salivary IgA, low-level laser intensifies the activation of B lymphocytes, which differentiate into plasma cells, thereby contributing to the increase in immunoglobulin levels.
The study of salivary aspects in malnourished children and possible treatments that can be used to improve salivary quality and quantity in these children has significant social relevance, as saliva is one of the main mechanisms against infection and participates in essential functions of life, such as swallowing and the maintenance of oral health.
An experimental cross-sectional study is proposed, which will be conducted at the Center for Educational and Nutrition Recovery in the city of Maceió, state of Alagoas, Brazil, and University Nove de Julho (UNINOVE) in the city of Sao Paulo, Brazil. This project has been approved by CESMAC ethics committee (CAAE 71961317.1.0000.0039).
- Conditions
- Malnutrition, Child
- Being tested
- Low level Light therapy
- Keywords
- saliva, Low-level light therapy, salivary glands
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level Light therapyRadiation
Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.
| Study group | Role | What they receive |
|---|---|---|
| Low level light therapy 1 | Experimental | Not described Receives: Radiation: Low level Light therapy |
| Low level light therapy 2 | Experimental | Not described Receives: Radiation: Low level Light therapy |
| Low level light therapy 3 | Experimental | Not described Receives: Radiation: Low level Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-level laser irradiation on the salivary glands
Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.
The laser will be adjusted according to the following parameters:
Central wavelength (nm)= 808, Spectral band width (FWHM) (nm)= 2, Operational mode= Continuous, Mean radiant power (mW)=100, Polarization= Randomized, Aperture diameter (cm) =0.2, Irradiation at aperture (mW/cm2)= 2500, Beam profile= Multimodal, Beam spot on target (cm2)= 0.04, Irradiation at target (mW/cm2)= 2500, Exposure time (s)= 40, Radiant exposure (J/cm2)=100.0, Radiant energy (J)= 4, Number of points irradiated=10, Irradiated area (cm2) =0.40, Application method= Contact, Number of treatment sessions= 3, Frequency of treatment sessions per week =1, Total radiant energy (J) =40.
Measured: 3 weeks
Secondary outcomes (5)
Length/Height
Length - A wooden measuring board (also called sliding board) will be used for measuring the length of children under two years old to the nearest millimetre.
Height - This is measured with the child in a standing position.
Measured: 1 week
Weight
A weighing sling (spring balance), also called the 'Salter Scale' will be used for measuring the weight of children under two years old, to the nearest 0.1 kg. Children over two years a beam balance will be used and the measurement is also to the nearest 0.1 kg.
Measured: 1 week
Saliva flow rate measurement
Salivary flow rates can be reduced significantly in individuals who have suffered severe malnutrition in early childhood.
Saliva parameters of children with malnutrition will be measured and compared to normal values.
Total resting saliva will be collected between 9 and 11 am (to avoid the influence of circadian rhythm) using the drainage method.
The child will be instructed to swallow prior to the collection and then instructed not to swallow, allowing the saliva to drain between the lips (which will be separated) into a test tube (aspirator) connected to a 15-mL Flacon tube positioned near the mouth.
Collection time will be five minutes. The volume of saliva will be measured and the salivary flow rate will be determined (mL/min).
Normal unstimulated salivary flux is above 0,2 ml/min. This measure was done in the samples of saliva before and after the lasertherapy for all patients.
Measured: 3 weeks
Buffering Capacity of saliva
One aliquot (1 ml) of saliva will be transferred immediately to a small tube (capacity: 5 ml) for titration with hydrochloric acid 0.005 Ne. The tube will be shaken for 15 seconds and buffering capacity will be measured using a glass electrode (Orion) coupled to a pH meter.
The reading of this test is performed based on the following parameters: pH 3.0 to 4.0 = very low to low buffering capacity; pH 4.5 to 5.0 = intermediate buffering capacity; and pH ≥ 5.5 = normal/good buffering capacity.
This measure was done in the samples of saliva before and after the lasertherapy for all patients.
Measured: 3 weeks
Analysis of salivary IgA
Concentrations of salivary IgA in all samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA) kit.
Salivary IgA (µg/ml) in each sample will be calculated using a standard curve obtained from the calibrators in the kit.
Normal saliva in children from 12 to 23 months = 2.3 ± 1.5 (mg/dl) Normal saliva in children from 24 to 71 months = 4.1 ± 2.4 (mg/dl) This measure was done in the samples of saliva before and after the lasertherapy for all patients.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Sep 2017
- Primary completion1 Oct 2017
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nutritional status of 50 children will be measured according the World Health Organization. The volume of saliva will be measured and, also, the salivary flow rate(mL/min) and buffering capacity will be determined. Concentrations of salivary IgA in all samples will be measured using a ELISA kit. Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands. Three sessions of laser therapy will occur (after the collection of saliva, 7 and 14 days after the first session, respectively). The final saliva collection will be performed after the third laser session. The laser will be adjusted according to the following parameters: 808nm, 4 J, Continuous and contact mode,100mW, Irradiation at target (mW/cm2)=2500,Irradiated area (cm2)=0.40.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355313
- Sponsor's protocol ID
- Malnutrition
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
PubMed 18207566Johansson I, Saellstrom AK, Rajan BP, Parameswaran A. Salivary flow and dental caries in Indian children suffering from chronic malnutrition. Caries Res. 1992;26(1):38-43. doi: 10.1159/000261425.
PubMed 1568235Vidovic Juras D, Lukac J, Cekic-Arambasin A, Vidovic A, Canjuga I, Sikora M, Carek A, Ledinsky M. Effects of low-level laser treatment on mouth dryness. Coll Antropol. 2010 Sep;34(3):1039-43.
PubMed 20977100Loncar B, Stipetic MM, Baricevic M, Risovic D. The effect of low-level laser therapy on salivary glands in patients with xerostomia. Photomed Laser Surg. 2011 Mar;29(3):171-5. doi: 10.1089/pho.2010.2792. Epub 2010 Nov 6.
PubMed 21054200Michalke B, Rossbach B, Goen T, Schaferhenrich A, Scherer G. Saliva as a matrix for human biomonitoring in occupational and environmental medicine. Int Arch Occup Environ Health. 2015 Jan;88(1):1-44. doi: 10.1007/s00420-014-0938-5. Epub 2014 Mar 12.
PubMed 24619390Navazesh M, Christensen CM. A comparison of whole mouth resting and stimulated salivary measurement procedures. J Dent Res. 1982 Oct;61(10):1158-62. doi: 10.1177/00220345820610100901. No abstract available.
PubMed 6956596Psoter WJ, Spielman AL, Gebrian B, St Jean R, Katz RV. Effect of childhood malnutrition on salivary flow and pH. Arch Oral Biol. 2008 Mar;53(3):231-7. doi: 10.1016/j.archoralbio.2007.09.007. Epub 2007 Nov 5.
PubMed 17983611Reddy V, Raghuramulu N, Bhaskaram C. Secretory IgA in protein-calorie malnutrition. Arch Dis Child. 1976 Nov;51(11):871-4. doi: 10.1136/adc.51.11.871.
PubMed 827242Rodriguez PN, Martinez Reinoso J, Gamba CA, Salgado PA, Mateo MT, Manto Mdel C, Molgatini SL, Iglesias V, Argentieri AB. Association among salivary flow rate, caries risk and nutritional status in pre-schoolers. Acta Odontol Latinoam. 2015;28(2):185-91. doi: 10.1590/S1852-48342015000200015.
PubMed 26355891Simoes A, de Campos L, de Souza DN, de Matos JA, Freitas PM, Nicolau J. Laser phototherapy as topical prophylaxis against radiation-induced xerostomia. Photomed Laser Surg. 2010 Jun;28(3):357-63. doi: 10.1089/pho.2009.2486.
PubMed 19814701Vieira KA, Bastos CM, Vitor MGC, Deana AM, Fernandes KPS, Rodrigues MFSD, Pavesi VCS, Bussadori SK. Use of low-level laser therapy on children aged 1 to 5 years with energy-protein malnutrition: A clinical trial. Medicine (Baltimore). 2018 Apr;97(17):e0538. doi: 10.1097/MD.0000000000010538.
PubMed 29703031
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition
- ClinicalTrials.gov ID
- NCT03355313
- Acronym / sponsor ID
- Malnutrition
- Conditions
- Malnutrition, Child
- Keywords
- saliva, Low-level light therapy, salivary glands
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 28 Nov 2017 (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.
Malnutrition is a clinical-social disease caused by multiple prenatal, intrauterine and postnatal factors as well as social, political and cultural determinants (distal causes). Despite the global and national reductions in the number of cases, malnutrition continues to be a public health problem, with greater prevalence in pockets of poverty found in the northern and northeastern regions of Brazil.
Episodes of malnutrition in early childhood, with consequent calcium, phosphate and vitamin A, C and D deficiencies, can increase one's susceptibility to dental caries through three probable mechanisms: defects in tooth formation (odontogenesis), delayed tooth eruption and alterations in the salivary glands.
It is likely that the significant increase in susceptibility to caries in malnourished individuals stems from alterations in the salivary secretion rate, since a reduction in salivary flow (salivary gland atrophy) increases the susceptibility to both dental caries and dental erosion. As saliva is the main defense factor of the oral cavity, a reduction/change in its physical properties (secretion rate and buffering capacity) can cause immunological disorders that affect an individual's defense capacity.
Studies have demonstrated that salivary immunoglobulin A (IgA) also plays an important role in the immunity of the oral mucosa. Indeed, patients with IgA deficiency can experience recurring upper airway (tonsillitis, ear infection and sinusitis), lower airway (pneumonia) and gastrointestinal (diarrhea and parasitosis) infections.
The investigation of mechanisms that can reduce the impact of malnutrition on the defenses of the organism is of the utmost important and interest to public health. Among such mechanisms, low-level laser therapy has demonstrated effectiveness in the treatment of diverse conditions and disease through the promotion of the biomodulation of the cell metabolism and due to its analgesic and anti-inflammatory properties with no mutagenic or photothermal effects.
Detailed description
Laser stimulation of the major salivary glands to produce more saliva occurs through the increase in local circulation due to vasodilatation, the induction of the proliferation of glandular cells and cell respiration/ATP (adenosine triphosphate) synthesis as well as the release of growth factors and cytokines to stimulate protein exocytosis. With regard to an increase in salivary IgA, low-level laser intensifies the activation of B lymphocytes, which differentiate into plasma cells, thereby contributing to the increase in immunoglobulin levels.
The study of salivary aspects in malnourished children and possible treatments that can be used to improve salivary quality and quantity in these children has significant social relevance, as saliva is one of the main mechanisms against infection and participates in essential functions of life, such as swallowing and the maintenance of oral health.
An experimental cross-sectional study is proposed, which will be conducted at the Center for Educational and Nutrition Recovery in the city of Maceió, state of Alagoas, Brazil, and University Nove de Julho (UNINOVE) in the city of Sao Paulo, Brazil. This project has been approved by CESMAC ethics committee (CAAE 71961317.1.0000.0039).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Nutritional status of 50 children will be measured according the World Health Organization. The volume of saliva will be measured and, also, the salivary flow rate(mL/min) and buffering capacity will be determined. Concentrations of salivary IgA in all samples will be measured using a ELISA kit. Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands. Three sessions of laser therapy will occur (after the collection of saliva, 7 and 14 days after the first session, respectively). The final saliva collection will be performed after the third laser session. The laser will be adjusted according to the following parameters: 808nm, 4 J, Continuous and contact mode,100mW, Irradiation at target (mW/cm2)=2500,Irradiated area (cm2)=0.40.
| Arm | Type | Receives |
|---|---|---|
| Low level light therapy 1 | Experimental | Radiation: Low level Light therapy |
| Low level light therapy 2 | Experimental | Radiation: Low level Light therapy |
| Low level light therapy 3 | Experimental | Radiation: Low level Light therapy |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged one to five years enrolled at the Center for Educational and Nutrition Recovery in the city of Maceió whose parent/guardians signed as statement of informed consent agreeing to the participation of the children.
- Children suffering of malnutrition.
Key exclusion criteria (2 listed)
- Children aged one to five years not enrolled at the Center for Educational and Nutrition Recovery in the city of Maceió and children whose parents/guardians did not sign a statement of informed consent.
- Children not suffering of malnutrition.
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 |
|---|---|---|
| Low level Light therapyLaser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands. | Radiation | Low level light therapy 1, Low level light therapy 2, Low level light therapy 3 |
Primary outcome
Low-level laser irradiation on the salivary glands
Time frame: 3 weeks
Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands. The laser will be adjusted according to the following parameters: Central wavelength (nm)= 808, Spectral band width (FWHM) (nm)= 2, Operational mode= Continuous, Mean radiant power (mW)=100, Polarization= Randomized, Aperture diameter (cm) =0.2, Irradiation at aperture (mW/cm2)= 2500, Beam profile= Multimodal, Beam spot on target (cm2)= 0.04, Irradiation at target (mW/cm2)= 2500, Exposure time (s)= 40, Radiant exposure (J/cm2)=100.0, Radiant energy (J)= 4, Number of points irradiated=10, Irradiated area (cm2) =0.40, Application method= Contact, Number of treatment sessions= 3, Frequency of treatment sessions per week =1, Total radiant energy (J) =40.
5 secondary outcomes
Length/Height
Time frame: 1 week
Weight
Time frame: 1 week
Saliva flow rate measurement
Time frame: 3 weeks
Buffering Capacity of saliva
Time frame: 3 weeks
Analysis of salivary IgA
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 18207566Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
- Background: PubMed 1568235Johansson I, Saellstrom AK, Rajan BP, Parameswaran A. Salivary flow and dental caries in Indian children suffering from chronic malnutrition. Caries Res. 1992;26(1):38-43. doi: 10.1159/000261425.
- Background: PubMed 20977100Vidovic Juras D, Lukac J, Cekic-Arambasin A, Vidovic A, Canjuga I, Sikora M, Carek A, Ledinsky M. Effects of low-level laser treatment on mouth dryness. Coll Antropol. 2010 Sep;34(3):1039-43.
- Background: PubMed 21054200Loncar B, Stipetic MM, Baricevic M, Risovic D. The effect of low-level laser therapy on salivary glands in patients with xerostomia. Photomed Laser Surg. 2011 Mar;29(3):171-5. doi: 10.1089/pho.2010.2792. Epub 2010 Nov 6.
- Background: PubMed 24619390Michalke B, Rossbach B, Goen T, Schaferhenrich A, Scherer G. Saliva as a matrix for human biomonitoring in occupational and environmental medicine. Int Arch Occup Environ Health. 2015 Jan;88(1):1-44. doi: 10.1007/s00420-014-0938-5. Epub 2014 Mar 12.
- Background: PubMed 6956596Navazesh M, Christensen CM. A comparison of whole mouth resting and stimulated salivary measurement procedures. J Dent Res. 1982 Oct;61(10):1158-62. doi: 10.1177/00220345820610100901. No abstract available.
- Background: PubMed 17983611Psoter WJ, Spielman AL, Gebrian B, St Jean R, Katz RV. Effect of childhood malnutrition on salivary flow and pH. Arch Oral Biol. 2008 Mar;53(3):231-7. doi: 10.1016/j.archoralbio.2007.09.007. Epub 2007 Nov 5.
- Background: PubMed 827242Reddy V, Raghuramulu N, Bhaskaram C. Secretory IgA in protein-calorie malnutrition. Arch Dis Child. 1976 Nov;51(11):871-4. doi: 10.1136/adc.51.11.871.
- Background: PubMed 26355891Rodriguez PN, Martinez Reinoso J, Gamba CA, Salgado PA, Mateo MT, Manto Mdel C, Molgatini SL, Iglesias V, Argentieri AB. Association among salivary flow rate, caries risk and nutritional status in pre-schoolers. Acta Odontol Latinoam. 2015;28(2):185-91. doi: 10.1590/S1852-48342015000200015.
- Background: PubMed 19814701Simoes A, de Campos L, de Souza DN, de Matos JA, Freitas PM, Nicolau J. Laser phototherapy as topical prophylaxis against radiation-induced xerostomia. Photomed Laser Surg. 2010 Jun;28(3):357-63. doi: 10.1089/pho.2009.2486.
- Derived from this study: PubMed 29703031Vieira KA, Bastos CM, Vitor MGC, Deana AM, Fernandes KPS, Rodrigues MFSD, Pavesi VCS, Bussadori SK. Use of low-level laser therapy on children aged 1 to 5 years with energy-protein malnutrition: A clinical trial. Medicine (Baltimore). 2018 Apr;97(17):e0538. doi: 10.1097/MD.0000000000010538.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level Light therapy in people with Malnutrition, Child, run by University of Nove de Julho at 2 sites in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. 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?
Results are not available in the source record.
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?
Low-level laser irradiation on the salivary glands (time frame: 3 weeks). 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 NCT03355313, which also lists 11 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 28 Nov 2017.