Sleep Apnea Syndrome and Vitamin D
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|ClinicalTrials.gov Identifier: NCT01323218|
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : March 25, 2011
Last Update Posted : March 25, 2011
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities.
OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus.
A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea-hypopnea Syndrome||Drug: 25 OH vitamin D||Phase 2|
Prospective, longitudinal, double bind, randomized study of the effect of vitamin D supplementation in OSAHS patients with hypovitaminosis D.
After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||June 2012|
Drug: 25 OH vitamin D
- Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- Epworth sleepiness scale [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2) [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- Continuous positive airway pressure measured with a CPAP equipment [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- Muscular strength measured with handgrip test [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP) [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
- Analysis of genes implicated in vitamin D metabolism [ Time Frame: at inclusion. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323218
|Contact: Patrick LACARIN||04 73 75 11 firstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 email@example.com|