Systemic Nickel Allergic SyndromeDISTANCENCT04894331
Telemedicine for SNAS Patients in COVID-19 Pandemic
An observational study of Systemic Nickel Allergic Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care. In this context, "telemedicine" and, specifically, "tele-nutrition" (in nutritional field) allows remotely monitor and support food allergic patients subjected to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Nickel Allergic Syndrome
- What is being tested?
- Dietary intervention and Video call
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2020to 30 Nov 2020
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Ni-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).
Who may be able to join
- history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms);
- positive Ni-patch test;
- clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet;
- positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).
Who cannot join
- age < 18 years and >65 years;
- other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth;
- diabetes mellitus;
- hepatic, renal or cardiac dysfunction;
- thyroid disease or tumour;
- concomitant treatment with steroids and/or antihistamines in the previous 4 weeks;
Show all 9Show fewer
- pregnancy and lactation;
- smoking, abuse of alcohol, coffee, tea, and cola intake;
- inability to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet Intervention Study Through Telemedicine Assistance on SNAS Patients in COVID-19 Pandemic
Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care.
In this context, "telemedicine" and, specifically, "tele-nutrition" (in nutritional field) allows remotely monitor and support food allergic patients subjected to restricted diets using information and communication technologies.
Read more
The investigators focus attention on patients with diagnosis of Systemic Nickel Allergic Syndrome (SNAS) undergoing low-nickel diet to evaluate nutritional and psychological states through tele-nutrition tools during COVID-19 pandemic.
The aims of this study are: (a) to investigate dietary-nutritional status and, (b) to assess quality of life and adherence to dietary therapy before and after 30-day personalized diet therapy through tele-nutrition tools.
Each subject enrolled in the study goes allergological work-up to assess diagnosis of SNAS and following procedures: (a) face-to-face visit (nutritional visit and quality of life evaluation) concluding with prescription of one of five personalized and balanced dietary plans different for calory intake, (b) video call visit for dietary evaluation and assessment of adherence to diet after 15 days, and (c) video call visit for dietary and quality of life evaluation and assessment of adherence to diet therapy after 30 days (end of study).
Read the detailed description
There are no previous studies focused on the tele-nutrition for the evaluation of dietary-nutritional status of patients suffered from Systemic Nickel Allergic Syndrome (SNAS).
The aims of this study are (a) to investigate dietary-nutritional status (primary outcome) and, (b) to assess quality of life (QoL) and adherence to dietary therapy (secondary outcomes) of SNAS patients before and after personalized diet therapy through tele-nutrition tools at time of COVID-19 pandemic.
The investigators perform a prospective, single-center, observational study enrolling SNAS patients in order to evaluate dietary-nutritional status and QoL, before and after 30-day personalized diet therapy, and adherence to low Ni diet, through tele-nutrition tools, during COVID-19 pandemic.
The study is performed at the Allergology Unit and Dietetics and Clinical Nutrition Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy.
All enrolled patients give their signed informed consent to participation in the study.
The investigators enroll patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Nickel (Ni)-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO). Exclusion criteria include (a) age < 18 years and >65 years; (b) other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth; (c) diabetes mellitus; (d) hepatic, renal or cardiac dysfunction; (e) thyroid disease or tumour; (f) concomitant treatment with steroids and/or antihistamines in the previous 4 weeks; (g) pregnancy and lactation; (h) smoking, abuse of alcohol, coffee, tea, and cola intake, and (i) inability to give written informed consent.
Patients go pre-diet face-to-face visit (time 0, T0), complete 30-day personalized diet and, then, go follow-up remote visit through video call (time 2, T2). A further video call is performed 15 days after the start of the diet therapy treatment (time 1, T1).
The study uses the commercially available online platform Microsoft Teams, which is included in the Fondazione Policlinico Universitario A. Gemelli IRCCS's Microsoft Office 365 package.
Variables The investigators select two primary outcome measurements (dietary assessment and anthropometric data) to evaluate dietary-nutritional status of SNAS patients. Moreover, the investigators adopt Short-Form 36-Item Health Survey (SF-36v2) questionnaire as tool to evaluate QoL (secondary outcome). Finally, adherence to diet therapy (secondary outcome) is investigated through video call at T1 and T2.
Measurement
Study procedures:
T0 face-to-face visit:
- Dietary assessment: nutritional history and eating habits.
- Collection of anthropometric data.
- QoL evaluation. Each patient answers SF-36v2 (Italian version) questionnaire. At the end of visit, each patient receives one of 5 dietary plans, different only for energy intake (1400-1600-1800-2000-2100 Kcal/day). The choice depended on the personalized energy needs.
All dietary plans include foods with low-Ni content.
T1 video call visit:
- Dietary assessment: collection of anthropometric data.
- Assessment of adherence to dietary therapy through question "How many days a week did the participant adhere to the prescribed dietary treatment? - Two possible mutually exclusive answers: 1) <5 days a week, 2) ≥ 5 days a week.
T2 video call visit:
- Dietary evaluation: collection of anthropometric data.
- Assessment of adherence to the dietary treatment.
- QoL evaluation.
- Conditions
- Systemic Nickel Allergic Syndrome
- Being tested
- Dietary intervention, Video call
- Keywords
- Food Allergy, COVID-19, Telemedicine, Telenutrition, Quality of Life, Systemic Nickel Allergic Syndrome
- Medical subject headings
- Food Hypersensitivity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Also called Diet therapy
Each patient receives one of 5 dietary plans, different only for energy intake (1400-1600-1800-2000-2100 Kcal/day). The choice depends on the personalized energy needs. The energy requirement is calculated on basal metabolic rate (BMR) of the patient according to Harris \& Benedict's and Schofield's formulas.
All dietary plans include foods with low-Ni content. Finally, each patient completes 30-day personalized diet.
Video callOther
Also called Telenutrition tool
Each patient receives a follow-up remote visit through video call 15 and 30 days after the start of the dietary intervention.
| Study group | Role | What they receive |
|---|---|---|
| SNAS patients | Patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Ni-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO). Exclusion criteria include (a) age < 18 years and >65 years; (b) other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth; (c) diabetes mellitus; (d) hepatic, renal or cardiac dysfunction; (e) thyroid disease or tumour; (f) concomitant treatment with steroids and/or antihistamines in the previous 4 weeks; (g) pregnancy and lactation; (h) smoking, abuse of alcohol, coffee, tea, and cola intake, and (i) inability to give written informed consent. Receives: Other: Dietary intervention; Other: Video call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary assessment
Dietary assessment includes questionnaire on 1) drinking alcohol, 2) particular diet (such as vegetarian, vegan or raw food), 3) number of meals per day, 4) same time for meals, 5) place of lunch on non-holiday, 6) frequency of eat away from home (times per week), 7) water intake, and 8) frequency of consumption of foods (desserts, processed meat, red meat, eggs, legumes, milk and derivatives, white meat, bread/pasta/rice, fish fruit and vegetable).
Measured: At enrollment
Change of body mass index (BMI)
Collection of weight in kilograms and height in meters will be combined to report BMI in kg/m^2.
Measured: Change from Baseline BMI at 15 and 30 days
Change of circumference of wrist
Collection of anthropometric data: circumference of wrist in centimeters.
Measured: Change from Baseline circumference of wrist at 15 and 30 days
Change of circumference of arm
Collection of anthropometric data: circumference of arm in centimeters.
Measured: Change from Baseline circumference of arm at 15 and 30 days
Change of circumference of waist
Collection of anthropometric data: circumference of waist in centimeters.
Measured: Change from Baseline circumference of waist at 15 and 30 days
Change of circumference of hip
Collection of anthropometric data: circumference of hip in centimeters.
Measured: Change from Baseline circumference of hip at 15 and 30 days
Secondary outcomes (2)
State of well-being
Each patient answers SF-36v2 (Italian version) questionnaire. It comprises 36-items measuring eight dimensions of general QoL. Each question's score is coded, summed up, and transformed to a scale of 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
Measured: At enrollment, after 30 days
Adherence to dietary therapy
Assessment of adherence to dietary therapy through question "How many days a week did you adhere to the prescribed dietary treatment? - Two possible mutually exclusive answers: 1) <5 days a week, 2) ≥ 5 days a week.
Measured: After 15 days, after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start8 Oct 2020
- Primary completion23 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Nickel Allergic SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Nucera, Catholic University of the Sacred Heart
- Investigators
- Eleonora Nucera, Prof., MD, Principal investigator, Catholic University of the Sacred HeartAntonio Gasbarrini, Prof., MD, Study director, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894331
- Sponsor's protocol ID
- ID 3448
- Acronym
- DISTANCE
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Intervention Study Through Telemedicine Assistance on SNAS Patients in COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04894331
- Acronym / sponsor ID
- DISTANCE / ID 3448
- Conditions
- Systemic Nickel Allergic Syndrome
- Keywords
- Food Allergy, COVID-19, Telemedicine, Telenutrition, Quality of Life, Systemic Nickel Allergic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 20 May 2021 (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.
Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care.
In this context, "telemedicine" and, specifically, "tele-nutrition" (in nutritional field) allows remotely monitor and support food allergic patients subjected to restricted diets using information and communication technologies.
The investigators focus attention on patients with diagnosis of Systemic Nickel Allergic Syndrome (SNAS) undergoing low-nickel diet to evaluate nutritional and psychological states through tele-nutrition tools during COVID-19 pandemic.
The aims of this study are: (a) to investigate dietary-nutritional status and, (b) to assess quality of life and adherence to dietary therapy before and after 30-day personalized diet therapy through tele-nutrition tools.
Each subject enrolled in the study goes allergological work-up to assess diagnosis of SNAS and following procedures: (a) face-to-face visit (nutritional visit and quality of life evaluation) concluding with prescription of one of five personalized and balanced dietary plans different for calory intake, (b) video call visit for dietary evaluation and assessment of adherence to diet after 15 days, and (c) video call visit for dietary and quality of life evaluation and assessment of adherence to diet therapy after 30 days (end of study).
Detailed description
There are no previous studies focused on the tele-nutrition for the evaluation of dietary-nutritional status of patients suffered from Systemic Nickel Allergic Syndrome (SNAS).
The aims of this study are (a) to investigate dietary-nutritional status (primary outcome) and, (b) to assess quality of life (QoL) and adherence to dietary therapy (secondary outcomes) of SNAS patients before and after personalized diet therapy through tele-nutrition tools at time of COVID-19 pandemic.
The investigators perform a prospective, single-center, observational study enrolling SNAS patients in order to evaluate dietary-nutritional status and QoL, before and after 30-day personalized diet therapy, and adherence to low Ni diet, through tele-nutrition tools, during COVID-19 pandemic.
The study is performed at the Allergology Unit and Dietetics and Clinical Nutrition Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy.
All enrolled patients give their signed informed consent to participation in the study.
The investigators enroll patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Nickel (Ni)-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO). Exclusion criteria include (a) age < 18 years and >65 years; (b) other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth; (c) diabetes mellitus; (d) hepatic, renal or cardiac dysfunction; (e) thyroid disease or tumour; (f) concomitant treatment with steroids and/or antihistamines in the previous 4 weeks; (g) pregnancy and lactation; (h) smoking, abuse of alcohol, coffee, tea, and cola intake, and (i) inability to give written informed consent.
Patients go pre-diet face-to-face visit (time 0, T0), complete 30-day personalized diet and, then, go follow-up remote visit through video call (time 2, T2). A further video call is performed 15 days after the start of the diet therapy treatment (time 1, T1).
The study uses the commercially available online platform Microsoft Teams, which is included in the Fondazione Policlinico Universitario A. Gemelli IRCCS's Microsoft Office 365 package.
Variables The investigators select two primary outcome measurements (dietary assessment and anthropometric data) to evaluate dietary-nutritional status of SNAS patients. Moreover, the investigators adopt Short-Form 36-Item Health Survey (SF-36v2) questionnaire as tool to evaluate QoL (secondary outcome). Finally, adherence to diet therapy (secondary outcome) is investigated through video call at T1 and T2.
Measurement
Study procedures:
T0 face-to-face visit:
- Dietary assessment: nutritional history and eating habits.
- Collection of anthropometric data.
- QoL evaluation. Each patient answers SF-36v2 (Italian version) questionnaire. At the end of visit, each patient receives one of 5 dietary plans, different only for energy intake (1400-1600-1800-2000-2100 Kcal/day). The choice depended on the personalized energy needs.
All dietary plans include foods with low-Ni content.
T1 video call visit:
- Dietary assessment: collection of anthropometric data.
- Assessment of adherence to dietary therapy through question "How many days a week did the participant adhere to the prescribed dietary treatment? - Two possible mutually exclusive answers: 1) <5 days a week, 2) ≥ 5 days a week.
T2 video call visit:
- Dietary evaluation: collection of anthropometric data.
- Assessment of adherence to the dietary treatment.
- QoL evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNAS patients | – | Other: Dietary intervention, Other: Video callPatients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Ni-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO). Exclusion criteria include (a) age < 18 years and >65 years; (b) other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth; (c) diabetes mellitus; (d) hepatic, renal or cardiac dysfunction; (e) thyroid disease or tumour; (f) concomitant treatment with steroids and/or antihistamines in the previous 4 weeks; (g) pregnancy and lactation; (h) smoking, abuse of alcohol, coffee, tea, and cola intake, and (i) inability to give written informed consent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Ni-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).
Key inclusion criteria (4 listed)
- history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms);
- positive Ni-patch test;
- clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet;
- positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).
Key exclusion criteria (9 listed)
- age < 18 years and >65 years;
- other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth;
- diabetes mellitus;
- hepatic, renal or cardiac dysfunction;
- thyroid disease or tumour;
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 |
|---|---|---|
| Dietary interventionAlso: Diet therapyEach patient receives one of 5 dietary plans, different only for energy intake (1400-1600-1800-2000-2100 Kcal/day). The choice depends on the personalized energy needs. The energy requirement is calculated on basal metabolic rate (BMR) of the patient according to Harris \& Benedict's and Schofield's formulas. All dietary plans include foods with low-Ni content. Finally, each patient completes 30-day personalized diet. | Other | SNAS patients |
| Video callAlso: Telenutrition toolEach patient receives a follow-up remote visit through video call 15 and 30 days after the start of the dietary intervention. | Other | SNAS patients |
Primary outcome
Dietary assessment
Time frame: At enrollment
Dietary assessment includes questionnaire on 1) drinking alcohol, 2) particular diet (such as vegetarian, vegan or raw food), 3) number of meals per day, 4) same time for meals, 5) place of lunch on non-holiday, 6) frequency of eat away from home (times per week), 7) water intake, and 8) frequency of consumption of foods (desserts, processed meat, red meat, eggs, legumes, milk and derivatives, white meat, bread/pasta/rice, fish fruit and vegetable).
Change of body mass index (BMI)
Time frame: Change from Baseline BMI at 15 and 30 days
Collection of weight in kilograms and height in meters will be combined to report BMI in kg/m^2.
Change of circumference of wrist
Time frame: Change from Baseline circumference of wrist at 15 and 30 days
Collection of anthropometric data: circumference of wrist in centimeters.
Change of circumference of arm
Time frame: Change from Baseline circumference of arm at 15 and 30 days
Collection of anthropometric data: circumference of arm in centimeters.
Change of circumference of waist
Time frame: Change from Baseline circumference of waist at 15 and 30 days
Collection of anthropometric data: circumference of waist in centimeters.
Change of circumference of hip
Time frame: Change from Baseline circumference of hip at 15 and 30 days
Collection of anthropometric data: circumference of hip in centimeters.
2 secondary outcomes
State of well-being
Time frame: At enrollment, after 30 days
Adherence to dietary therapy
Time frame: After 15 days, after 30 days
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 20 May 2021.
- Individual participant dataSharing planned: No
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.
Eleonora Nucera, Prof., MD principal investigator
Catholic University of the Sacred Heart
Antonio Gasbarrini, Prof., MD study director
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Nickel Allergic Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 9 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 20 May 2021. 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 Italy. 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?
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?
Dietary assessment (time frame: At enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2021.