Down's syndrome in children males – biochemical characterisations in different media using non-randomised trial and systematic study

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00014074
• Date of registration: 10/04/2018
• Prospective Registration: No
• Primary sponsor: Department of Basic Sciences, Faculty of Dental Medicine, Damascus University, Main Highway, AlMazaa, Damascus, Syria
• Public title: Down's syndrome in children males – biochemical characterisations in different media using non-randomised trial and systematic study
• Scientific title: Down's syndrome in children males – biochemical characterisations in different media using non-randomised trial and systematic study - DSCM
• Date of first enrolment: 08/05/2016
• Target sample size: 225
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00014074
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: prevention
• Phase: N/A

Countries of recruitment

Syria

Contacts

• Name: Loai Aljerf
• Affiliation: Department of Basic Sciences, Faculty of Dental Medicine, Damascus University, Main Highway, AlMazaa, Damascus, Syria

• Name: Mazen Aljurf
• Affiliation: CosmeSurge Clinics, Bawsher State, Muscat, Sultanate of Oman, P.O. Box 1822, P.C. 130

Key inclusion & exclusion criteria

Inclusion criteria: Males, children, Permanent residences in Damascus, Living far from plaster dust sources of any possible adjacent construction sites and far from the industrial zone (incl. concrete plants), Non-smokers (all kinds of tobacco), Non-smoker families, Unstimulated saliva samples, Controls were healthy and non-diabetic young individuals, Controls had no systemic diseases or any local infection before 3 months and did not also take any medication for at least 3 months before sample collection, DS children patients were trisomy 21 diagnosed by karyotype test and assessed by clinical examination. Patients were euthyroid at the time of study as their thyroid-stimulating hormone (TSH) and free thyroxine hormone (FT4) were within the normal range.


Exclusion criteria: Females, Male smokers, Smoker families, Systemic diseases, Participant takes medication for at least 3 months, Children with congenital oligodontia and delayed eruption (more than 1yr), Individuals with the history of antibiotics, anticholinergic, antihistaminic and antipsychotic therapy two weeks prior to sample collection, intervened medications that could get in the way with ions metabolisms such as taking vitamin D, aspirin, or herbal medicine which can easily interfere for instance with Fe metabolism. In addition, candidates with concentrations of thiocyanate higher than 80 mg SCN-/L (1 mg SCN-/L =17.2 µM SCN-/L) saliva or 3.00 mg SCN-/L serum were excluded from the study.

Age minimum: 2 Years
Age maximum: 15 Years
Gender: Male

Health Condition(s) or Problem(s) studied

MedDRA - DOWN SYNDROME

Intervention(s)

Group 1: 71 DS (trisomy of chromosome 21 (21q22)) children received allocated to intervention with no discounted interventions or any lost to follow-up criterion. The procedure adopted in this work covered patients in 2016 and 2017 and was reported as consensus findings including further recommendations of the National Committee of Environmental Health Sciences (NCEHS) expert panel located in Damascus-Syria.
The whole study (incl. Duraphat treatment and both of the Results & Discussion) was terminated on 16 October 2017.
The salivary buffering capacity of the Down's syndrome (N =10× 5 repetitions) were measured. Periodontal, biochemical saliva, and elemental analyses in other biological samples were 145×3, 145×5, and 145×5, respectively. Health-related quality of life (HRQoL) was registered in 71 DS parents. HRQoL in both parents (father and mother) of DS children (6-15 years, 50×3) was assessed and tabulated. 71 DS patients prescribed different therapies for feeding difficulties and their Standard of Living was further assessed. Basic physiology and biochemistry were analysed in DS patients (23×3). However, due to a shrink available data related to the scope of this study, we compared only some data with previous studies and added proper justifications for new observations. In specific, launching from our observations, the oral prophylaxis, dental hygiene recommendations, and medical treatments were all described in more and sufficient details which can extremely avail both DS patients and doctors.
Each individual gave at least 40 mL of saliva in consecution during 14-55 days. The volume of parotid saliva and whole saliva were collected in as few collecting sessions as compatible with the rate of salivary flow rate (SFR) and subject co-operation, 30 min was the maxim

Primary Outcome(s)

Primary outcome: Biochemical change in saliva (control and DS patients)
Primary timepoint : 30 days post commencement of intervention and each individual gave at least 40 mL of saliva in consecution during 14-55 days. The volume of parotid saliva and whole saliva were collected in as few collecting sessions as compatible with the rate of salivary flow rate (SFR) and subject co-operation, 30 min was the maximum time allocated for any one meeting. Notably, parotid saliva was obtained from the subjects (DS and controls) using a modified Carlson-Crittenden device. In general, saliva was collected under petroleum ether (A.R.) (Sigma-Aldrich Chemie Gmbh, Munich, Germany) and these samples were collected in Salivette tubes (Sarstedt AG & Co., Nümbrecht, Oberbergischer Kreis, Germany) after overnight fasting.
The chemical analyses were included the following: pH, electrical conductivity (EC), total dissolved solids (TDS), total suspended solids (TSS), salinity, turbidity, colour, saliva flow rate (SFR), the decay, missing, and filled tooth (DMFT) index, glucose, total protein, carbon dioxide (CO2), total phosphorus (TP), total nitrogen (TN), major alkaline and alkaline-earth ions, aluminium (Al), silicon (Si), and heavy metals.

Secondary Outcome(s)

Secondary outcome: The oral health assessment (DS children) followed the protocol used in the National Oral Health Survey which was based on World Health Organization (WHO) guidelines
Secondary timepoint : The behavioural self-administered questionnaire was carried out 7 days post commencement of intervention for each individual and an oral health assessment (examination covered oral mucosal pathology, malocclusion, periodontal disease, dental caries and treatment needs) was executed by a single dental surgeon with experience in the dental examination of people with disability development (DD) 18 days post commencement of intervention.

Secondary outcome [1]: Dissolved CO2 in saliva using the micro-diffusion method of Conway.
Secondary timepoint [1]: The first day of sample collection and during 17-55 days post commencement of intervention.
Secondary outcome [2]: IgA determination in saliva using Stone method
Secondary timepoint [2]: The first day of sample collection and during 17-55 days post commencement of intervention.
Secondary outcome [3]: Total nitrogen of saliva determined by the micro-Kjeldahl method.
Secondary timepoint [3]: The first day of sample collection and during 17-55 days post commencement of intervention.
Secondary outcome [4]: The physical characterisation of saliva:
Ash weight measured by ASTM E1755-01 method, Saliva flow rate (SFR) measured by graduated syringes method, Viscosity measured by Ostwald-type capillary viscometer, Surface tension measured by Micro capillary rise apparatus, Electrical conductivity measured by ASTM D1125 method using MP-4 Portable Meter, Salinity measured by MP-4 Portable Meter, Total dissolved solids (TDS) measured by MP-4 Portable Meter using ASTM D5, Total suspended solids measured by ASTM D5907 method using DR 1900, and Turbidity measured by ASTM D1889 using 2100Q IS
Secondary timepoint [4]: The first day of sample collection and during 17-55 days post commencement of intervention.
Secondary outcome [5]: Total protein in saliva was measured at 546 nm by the colorimetric method using acid violet pigment (AV17)
Secondary timepoint [5]: 3 days post commencement of intervention.
Secondary outcome [6]: Health-related quality of life (HRQoL) in both parents of children
Secondary timepoint [6]: 3 days post commencement of intervention.
Secondary outcome [7]: Maladaptive behaviour profile (aggression, anxiety, attention, depression, hyperactivity, somatisation, and withdrawal)
Secondary timepoint [7]: 7 days post commencement of intervention
Secondary outcome [8]: Challenging behaviours analysis as argumentativeness, disobedience, stubbornness, depression and conduct problems (i.e. neurophysiologic, feeding difficulties and food pocketing or packing).
Secondary timepoint [8]: 7 days post commencement of intervention
Secondary outcome [9]: Therapies employed for feeding difficulties have involved the following procedures: Feeding therapy use, Speech-language pathologist, Reflux medication use, Liquid or solid chaser use when eating, Past use of modified utensils when eating, Occupational therapist, Surgeries for eating and swallowing, Current use of modified utensils when eating, Therapy to reduce saliva, Have to remove food from cheeks when eating, and Psychologist. The count and the percent of collaboration for each procedure were registered.
Secondary timepoint [9]: 65 days post commencement of intervention.
Secondary outcome [10]: Physiological study:
Descriptive variables: Age, IQ, Height (cm), Stature (cm), Weight (kg), BMI (kg m-2), BMD of the lumbar Vertebrae (g cm-2)
Body composition: TBF (%) and WC (cm)
Energy balance: TEI (kcal), TEE (kcal), and TEB (kcal)
Body mass index (BMI), Bone mineral density (BMD), White blood cells or leukocytes (WBCs), Haemoglobin (Hb or Hgb), Haematocrit (Ht or HCT), Milli-international units (mIU), Creatinine (CR), Procollagen type 1 N propeptide (P1NP), C-terminal telopeptide (CTx), High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C), Triglyceride (TG), Blood glucose (BG), C-reactive protein (CRP), Homocysteine (HCY), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Triiodothyronine Free serum (Free T3), Thyroxin Free serum (Free T4), Total body fat (TBF), Waist circumference (WC), Total energy intake (TEI), Total energy expenditure (TEE), Total energy balance (TEB)
Cholesterol profiles, triglycerides, and glucose levels were determined by colorimetric reflectance spectrophotometry. CRP was analysed with an ultrasensitive assay using rate nephelometry. Insulin was determined by chemiluminescent immunoassay. Homocysteine was determined through a fluorescence polarisation immunoassay. Seated auscultatory blood pressure was measured with a mercury sphygmomanometer according to the guidelines established by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. With participants dressed in lightweight clothing, weight was measured to the nearest 0.5 kg. Height was measured to the nearest 0.5 cm. BMI was calculated by dividing the weight in kilograms by the height squared in meters squared. Total body fat was assessed by dual-energy x-ray absorptiometry (Prodigy, software version 6.7; GE Medical Systems, Madison, Wisconsin). Waist circumference was measured to the nearest 0.1 cm with a cloth measuring tape. BMD of the lumbar vertebrae was measured in posteroanterior (PA) projection.
Note our patients have not taken Na-drugs as sodium zirconium cyclosilicate (ZS-9: (2Na•H2O•3H4SiO4•H4ZrO6)n) and no cardiorenal diseases (incl. kidney) observed and no agents taken to control plasma of K+
Secondary timepoint [10]: The first day of sample collection and during 10-100 days post commencement of intervention.
Secondary outcome [11]: Cyanide (CN-) measured in saliva, blood, urine, and hair by ASTM D2036-09(2015) method using DR 1900 (Hach, Colorado, USA)
Secondary timepoint [11]: 30 days post commencement of intervention.
Secondary outcome [12]: Thiocyanate (SCN-) measured in saliva, blood, urine, and hair by ASTM D4193-08(2013)e1 method using DR 1900 (Hach, Colorado, USA)
Secondary timepoint [12]: 30 days post commencement of intervention.
Secondary outcome [13]: Total nitrogen (TN) measured in saliva by ASTM D8083 – 16 method using Micro Kjeldahl Apparatus (Labconco, Kansas, MO, USA)
Secondary timepoint [13]: 30 days post commencement of intervention.
Secondary outcome [14]: Sodium (Na) and potassium (K) analyses in saliva, blood, urine, and hair measured by ASTM D1428 using Jenway PFP7 flame photometer (Jenway Gransmore Green Felsted, Essex, UK).
Secondary timepoint [14]: 33 days post commencement of intervention.
Secondary outcome [15]: Calcium (Ca) and magnesium (Mg) measured in saliva, blood, urine, and hair using Microlyte 6 analyser (Thermo Fisher Scientific Oy, Vantaa, Finland) and the method developed by our team (Aljerf and Maslah, 2017).
Secondary timepoint [15]: 35 days post commencement of intervention.
Secondary outcome [16]: Strontium (Sr) and barium (Ba) measured in saliva, blood, urine, and hair, using ICP-MS, Thermo Elemental, (Thermo Fisher Scientific, Waltham, MA, USA)
Secondary timepoint [16]: 38 days post commencement of intervention.
Secondary outcome [17]: Aluminium (Al) measured in saliva, blood, urine, and hair by ASTM D857 method using Acid extractable by the preliminary treatment and GTA-novAA 400 P (Analytik Jena AG , Jena, Germany)
Secondary timepoint [17]: 40 days post commencement of intervention.
Secondary outcome [18]: Silicon (Si) measured in saliva, blood, urine, and hair by ASTM D857 using Acid extractable by the preliminary treatment and GTA-novAA 400 P (Analytik Jena AG , Jena, Germany)
Secondary timepoint [18]: 42 days post commencement of intervention.
Secondary outcome [19]: Molybdenum (Mo), cop

Secondary ID(s)

U1111-1210-5037

Source(s) of Monetary Support

Department of Basic Sciences, Faculty of Dental Medicine, Damascus University, Main Highway, AlMazaa, Damascus, Syria

Ethics review

Status: Approved
Approval date: 28/10/2015
Contact:

Institutional Ethics Committee (IEC-FD-DU)-Faculty of Dental Medicine-Damascus University [Institutional Ethics Committee (IEC-FD-DU)-Faculty of Dental Medicine-Damascus University, P.O. 7535, Damascus, Syria]

Results

• Date Completed: 28/09/2017
• URL: http://drks.de/search/en/trial/DRKS00014074#studyResults