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临床试验/NCT06111664
NCT06111664招募中不适用

Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Prevalence of hypophosphatemia, DPi and SSL at the population level.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Subject having expressed opposition to participating in the study
  • Subject under judicial protection
  • Subject under guardianship or curatorship

结局指标

主要结局

Prevalence of hypophosphatemia, DPi and SSL at the population level.

时间窗: from 6 months after lithium treatment (Li+)

The prevalence is determined retrospectively on a population balanced on lithium (Li+) for more than 6 months.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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