Trial | NCT01323218  Report issue

Title

Sleep Apnea Syndrome and Vitamin D
Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    calcifediol ...

  • Study Participants

    80
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.
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 Started
Mar 31
2011
Primary Completion
Apr 30
2012
Anticipated
Study Completion
Jun 30
2012
Anticipated
Last Update
Mar 25
2011
Estimate

Drug 25 OH vitamin 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

Criteria 

Inclusion Criteria:

Moderate to severe obstructive sleep apnoea (AHI > 15)
With or without continuous positive airway pressure for a minimum of six months
aged 30-75 years
Vitamin D2D3 level < 30 ng/ml

Exclusion Criteria:

Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism
Patients with mixed sleep apnoea (central and obstructive)
Patients with CPAP use < 4 hours per night
Patients with maxillofacial or oro-pharyngeal diseases)
Patients with chronic respiratory failure, hypercapnic patients
Muscle diseases
Alcohol intake > 2 glasses per day
Body mass index > 40 kg/m2
No Results Posted