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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06111664
Other study ID # 8953
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date April 24, 2024

Study information

Verified date October 2023
Source University Hospital, Strasbourg, France
Contact Jack FOUCHER, MD, PhD
Phone 33 3 88 11 69 21
Email jack.foucher@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lithium (Li+) is prescribed to 1‰ of the French population (~ 60,000 patients). More than half of patients describe subjective symptoms linked to Li+ (SSL) similar to those of chronic fatigue syndrome: muscle weakness, fatigability, cognitive disorders, emotional blunting. SSL are the 2nd cause of stopping Li+ (28%), just behind kidney problems (30%). In animals, the administration of lithium (Li+) increases the urinary excretion of phosphate (Pi) by 6, inducing phosphate diabetes (DPi). However, idiopathic forms of DPi explain up to 10-15% of chronic fatigue syndromes and these disappear when supplementing with Pi (± vitamin D). In humans, the introduction of Li+ leads to a reduction in serum phosphate but we have not found any publication on the possible induction of DPi or on a possible link between DPi and SSL. However, the dosages necessary to detect a DPi are carried out during the annual follow-up assessment of patients on Li+. All you have to do is calculate the standardized maximum reabsorption rate of Pi (TmPi) to make the diagnosis! Finally, if the patients presenting with DPi turn out to be the same as those who complain of SSL, we can imagine that correcting the first by simple supplementation with Pi (± vitamin D) could provide relief.


Description:

The aim of the study is to determine the prevalence of hypophosphatemia, DPi and SSL in a population of ambulatory patients controlled on Li+ (> 6 months).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 24, 2024
Est. primary completion date April 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Major subject (= 18 years old) - Man or woman - Subject balanced on Li+ (> 6 months, regardless of the underlying pathology). - Outpatient monitoring by one of the members of CEDRA (Alsace expert center for resistant depression). - Subject not opposing, after information, the reuse of their data for the purposes of this research Exclusion Criteria: - Subject having expressed opposition to participating in the study - Subject under judicial protection - Subject under guardianship or curatorship

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of hypophosphatemia, DPi and SSL at the population level. The prevalence is determined retrospectively on a population balanced on lithium (Li+) for more than 6 months. from 6 months after lithium treatment (Li+)
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