Testing the effectiveness and safety of alpha-lipoic acid for pain reduction
| ISRCTN | ISRCTN89876422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89876422 |
| Secondary identifying numbers | ALA121 |
- Submission date
- 27/05/2021
- Registration date
- 21/06/2021
- Last edited
- 08/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
α-lipoic acid (ALA) is a substance produced by the human gut with antioxidant and anti-inflammatory activities. ALA can also decrease blood sugar levels in patients with high blood sugar.
Clinical studies have found that ALA has a beneficial effect in patients suffering from different kinds of acute and chronic pain. Its safety was also demonstrated in pregnant women. Other clinical trials reported infrequent adverse effects such as allergic skin reactions, gastrointestinal symptoms and dizziness.
The aim of this study is to evaluate the effectiveness of ALA treatment, taken orally, at reducing different kinds of acute and chronic pain at two doses (800 and 400 mg/day).
Who can participate?
Patients aged 18-75 years with arthralgia (joint pain), primitive neuropathic pain or idiopathic myalgia (muscle pain), who cannot or do not want to take analgesic (painkiller) drugs, who have fasting blood sugar levels below 110 mg/dl
What does the study involve?
Participants are randomly allocated into three groups to take a daily dose of 800 mg/day of ALA (two tablets of 400 mg), 400 mg/day of ALA (one tablet of ALA and one tablet of placebo), or placebo (two tablets of placebo) for 2 months. Pain and blood sugar levels are measured at the start of the study and after 2 months.
What are the possible benefits and risks of participating?
Participants should have a benefit regarding pain. Participants will be continuously monitored and their liver and kidney function assessed.
Where is the study run from?
Comegen, Naples (Italy)
When is the study starting and how long is it expected to run for?
September 2020 to July 2021
Who is funding the study?
Italian Association of Health Products and Manufacturers - Federsalus (Italy)
Who is the main contact?
1. Prof. Maria Daglia (scientific)
maria.daglia@unina.it
2. Dr Cristina Esposito (public)
cristina.esposito@unina.it
Contact information
Scientific
Università degli Studi di Napoli Federico II Domenico
Montesano Street, 49
Naples
80131
Italy
 ORCID ID |
0000-0002-4870-7713 |
|---|---|
| Phone | +39 (0)3331703492 |
| maria.daglia@unina.it |
Public
Università degli Studi di Napoli Federico II
Domenico Montesano street, 49
Naples
80034
Italy
| Phone | +39 (0)81678644 |
|---|---|
| cristina.esposito@unina.it |
Study information
| Study design | Interventional monocentric randomized double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN89876422_PIS.pdf |
| Scientific title | Study on the efficacy and safety of an oral α-lipoic acid food supplement in the reduction of pain in different clinical settings: a monocentric, randomized, double-blind, placebo-controlled clinical trial |
| Study acronym | ALAES |
| Study hypothesis | The outcome of the study is to evaluate the efficacy and safety of α-lipoic acid (ALA) administration to normoglycaemic (or with a mild dysglycaemia) subjects with primary neuropathic pain, idiopathic myalgia or arthralgia, who cannot or do not want to take analgesic drugs (non-steroidal anti-inflammatory drugs). |
| Ethics approval(s) | Approved 19/11/2020, ASL Napoli 1 Centro Ethics Committee (Via Comunale del Principe, 13/A, 80145, Napoli, Italy; +39 (0)812544495; comitatoetico@aslnapoli1centro.it), ref: 532/C.E 16/2020 |
| Condition | Pain in different clinical settings (e.g. arthralgia, primitive neuropathic pain, idiopathic myalgia etc), fasting glycemia below 110 mg/dl |
| Intervention | The randomization sequence was generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list was kept hidden. The participants were assigned to each of the three treatment groups (ALA 800 mg/day), ALA (400 mg/day) and placebo casually and by simple randomisation (1:1:1 allocation ratio). The randomization code will consist of a three-digit number as indicated in the respective Case Report Form (CRF). In the clinical study 210 participants were enrolled and divided into three groups (70 for each group): Group 1: 800 mg/day of ALA (two tablets of 400 mg) to confirm the efficacy and safety Group 2: 400 mg/day of ALA (one tablet of ALA and one tablet of placebo), to confirm whether the minimal dose is potentially effective Group 3: placebo (two tablets of placebo) Participants underwent two visits (baseline = t0 and after 2 months = t1) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. In detail, the data acquired are: Baseline visit (t0): information on the sociodemographic, clinical and symptomatologic characteristics of the participants; numerical rating scale (NRS) and visual analogue scale (VAS) results; fasting blood glucose assessment; renal and hepatic toxicity assessment by blood test for the evaluation of creatinine level, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). After 2 months (t1): assessment of possible adverse reaction after the ingestion of the food supplement by a specific form based on the one used by the Italian Phytovigilance System (IPS), National Institute of Health; numerical rating scale (NRS) and visual analogue scale (VAS) results; fasting blood glucose assessment; renal and hepatic toxicity assessment by blood test for the evaluation of creatinine level, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). |
| Intervention type | Supplement |
| Primary outcome measure | 1. Pain measured using the Numerical Rating Scale (NRS) and the Visual Analogue Scale (VAS) at baseline (t0) and after 2 months (t1) 2. Fasting blood glucose in normoglycemic or mildly dysglycaemic subjects measured by taking a blood sample from participants who have fasted for at least 8 hours, at t0 and t1 |
| Secondary outcome measures | 1. Possible hepatic and renal toxicity resulting from oral administration of ALA by the evaluation of creatinine level, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) assessed by blood test at t0 and t2 2. Possible adverse reactions using a form specifically prepared according to the Italian Phytovigilance System (IPS) at t0 and t2 |
| Overall study start date | 09/09/2020 |
| Overall study end date | 30/07/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 210 |
| Total final enrolment | 210 |
| Participant inclusion criteria | 1. Patients of both sexes aged 18-75 years 2. Have arthralgia, primitive neuropathic pain, or idiopathic myalgia 3. Cannot or do not want to take analgesic drugs (non-steroidal anti-inflammatory drugs) 4. Fasting glycemia below 110 mg/dl 5. Signed informed consent |
| Participant exclusion criteria | 1. Pregnant women 2. Women suspected of being pregnant 3. Women who hope to become pregnant 4. Breastfeeding women 5. Patients with allergies 6. Congenital or acquired immunodeficiency syndrome 7. Fasting glycaemia above 110 mg/dl 8. Obese (body mass index >30 kg/m²) 9. Taking pharmacological therapy for diabetes, cardiovascular diseases, systemic chronic disease, or analgesic, anti-inflammatory or food supplements for the pain 10. Considered unsuitable for participation by the physician |
| Recruitment start date | 27/05/2021 |
| Recruitment end date | 10/06/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Naples
80126
Italy
Sponsor information
Industry
Via Brenta, 2/A
Roma
00144
Italy
| Phone | +39 (0)6 54 221 967 |
|---|---|
| federsalus@federsalus.it | |
| Website | https://www.federsalus.it/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 08/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Piccinocchi Gaetano (piccinocchi.gaetano@simg.it). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 08/07/2021 | No | Yes | ||
| Protocol file | 08/07/2021 | No | No | ||
| Results article | 12/10/2021 | 08/02/2022 | Yes | No |
Additional files
- ISRCTN89876422_PIS.pdf
- Uploaded 08/07/2021
- ISRCTN89876422_PROTOCOL.pdf
- Uploaded 08/07/2021
Editorial Notes
08/02/2022: Publication reference added.
08/07/2021: The participant information sheet has been uploaded. Uploaded protocol (not peer reviewed).
17/06/2021: Trial's existence confirmed by ASL Napoli 1 Centro Ethics Committee.
