AgingMONIALENCT03614988
Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly
A study testing Evening Levothyroxine Administration and Morning Levothyroxine Administration in people with Aging and Primary Hypothyroidism, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
A study designed to compare evening versus morning levothyroxine intake in the elderly. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Primary Hypothyroidism, Interaction Drug Food
- What is being tested?
- Evening Levothyroxine Administration and Morning Levothyroxine Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2018to 31 Mar 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 60 years or older who consult at the Geriatrics, Endocrinology and Internal Medicine Clinic at Hospital Clinicas de Porto Alegre
- Patients diagnosed with Primary Hypothyroidism
- Patients on levothyroxine for at least 6 months
- Patients with the same dose of levothyroxine for at least 3 months
Who cannot join
- Severe Dementia
- Severe Congestive Heart Failure (NYHA IV or / and three or more hospitalizations for heart failure within 1-year interval)
- Diagnosis of Advanced Stage Neoplasia
- Diagnosis of Thyroid Cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Renato Gorga Bandeira de Mello, 5133598152., rgmello@hcpa.edu.br
About this study
Official title: Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
A study designed to compare evening versus morning levothyroxine intake in the elderly.
Read the detailed description
This is a randomized crossover trial of two dosing strategies for pharmacological treatment of hypothyroidism in a sample of individuals aged 60 years or older, performed at an outpatient healthcare in a tertiary center.
- Conditions
- Aging, Primary Hypothyroidism, Interaction Drug Food
- Being tested
- Evening Levothyroxine Administration, Morning Levothyroxine Administration
- Keywords
- Polypharmacy, Elderly
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evening Levothyroxine AdministrationOther
Also called Bedtime Levothyroxine Administration
Bedtime levothyroxine intake, with 60-minute meal-free interval
Morning Levothyroxine AdministrationOther
Also called Before Breakfast Levothyroxine Administration
Morning levothyroxine intake, 60 minutes before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Morning Levothyroxine Intake First | Active comparator | Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration. Receives: Other: Evening Levothyroxine Administration |
| Evening Levothyroxine Intake First | Experimental | Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration. Receives: Other: Morning Levothyroxine Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in TSH (Thyroid-Stimulating Hormone) levels.
Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
Measured: 24 weeks.
Secondary outcomes (3)
Prevalence of drugs with potential drug interaction with levothyroxine.
To identify the major medications that interfere with the absorption of levothyroxine.
Measured: 24 weeks
Level of TSH (Thyroid-Stimulating Hormone) control in each group.
To compare the TSH (Thyroid-Stimulating Hormone) control efficacy between the two treatment strategies in this subgroup of participants.
Measured: 24 weeks
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
To assess the TSH (Thyroid-Stimulating Hormone) levels in this sample of patients at the time of study inclusion, in order to evaluate their real life in terms of adherence and relation with polypharmacy.
Measured: Baseline (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 May 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Renato Gorga Bandeira de Mello, Principal investigator, Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614988
- Sponsor's protocol ID
- 180209
- Acronym
- MONIALE
- Status last verified
- Oct 2019
- First submitted
- 30 Jul 2018
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giassi K, Piccoli V, da Costa Rodrigues T, Gorga Bandeira de Mello R. Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE). Trials. 2019 Dec 17;20(1):742. doi: 10.1186/s13063-019-3816-3.
PubMed 31847914
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
- ClinicalTrials.gov ID
- NCT03614988
- Acronym / sponsor ID
- MONIALE / 180209
- Conditions
- Aging, Primary Hypothyroidism, Interaction Drug Food
- Keywords
- Polypharmacy, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 3 Aug 2018 (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.
A study designed to compare evening versus morning levothyroxine intake in the elderly.
Detailed description
This is a randomized crossover trial of two dosing strategies for pharmacological treatment of hypothyroidism in a sample of individuals aged 60 years or older, performed at an outpatient healthcare in a tertiary center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Levothyroxine Intake First | Active comparator | Other: Evening Levothyroxine AdministrationRandomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration. |
| Evening Levothyroxine Intake First | Experimental | Other: Morning Levothyroxine AdministrationRandomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 60 years or older who consult at the Geriatrics, Endocrinology and Internal Medicine Clinic at Hospital Clinicas de Porto Alegre
- Patients diagnosed with Primary Hypothyroidism
- Patients on levothyroxine for at least 6 months
- Patients with the same dose of levothyroxine for at least 3 months
Key exclusion criteria (4 listed)
- Severe Dementia
- Severe Congestive Heart Failure (NYHA IV or / and three or more hospitalizations for heart failure within 1-year interval)
- Diagnosis of Advanced Stage Neoplasia
- Diagnosis of Thyroid Cancer
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 |
|---|---|---|
| Evening Levothyroxine AdministrationAlso: Bedtime Levothyroxine AdministrationBedtime levothyroxine intake, with 60-minute meal-free interval | Other | Morning Levothyroxine Intake First |
| Morning Levothyroxine AdministrationAlso: Before Breakfast Levothyroxine AdministrationMorning levothyroxine intake, 60 minutes before breakfast. | Other | Evening Levothyroxine Intake First |
Primary outcome
Variation in TSH (Thyroid-Stimulating Hormone) levels.
Time frame: 24 weeks.
Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
3 secondary outcomes
Prevalence of drugs with potential drug interaction with levothyroxine.
Time frame: 24 weeks
Level of TSH (Thyroid-Stimulating Hormone) control in each group.
Time frame: 24 weeks
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
Time frame: Baseline (0 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Derived from this study: PubMed 31847914Giassi K, Piccoli V, da Costa Rodrigues T, Gorga Bandeira de Mello R. Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE). Trials. 2019 Dec 17;20(1):742. doi: 10.1186/s13063-019-3816-3.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Renato Gorga Bandeira de Mello principal investigator
Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evening Levothyroxine Administration and Morning Levothyroxine Administration in people with Aging and Primary Hypothyroidism, run by Hospital de Clinicas de Porto Alegre at 1 site 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 4 inclusion and 4 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 14 Oct 2019. 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 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?
Contact Renato Gorga Bandeira de Mello (555133596400, rgmello@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in TSH (Thyroid-Stimulating Hormone) levels. (time frame: 24 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 NCT03614988, which also lists 1 linked publication.
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 14 Oct 2019.