Sleep Apnea Syndrome and Vitamin D

Obstructive Sleep Apnea-hypopnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01323218
• Other study ID #: CHU-0091
• Status: Recruiting
• Phase: Phase 2
• First received: March 24, 2011
• Last updated: March 24, 2011
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea-hypopnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Laboratoire Cidelec, Laboratoire Crinex

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	Epworth sleepiness scale		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2)		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	Continuous positive airway pressure measured with a CPAP equipment		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	Muscular strength measured with handgrip test		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)		at the beginning (day 0) and after 32 days of vitamin D supplementation	Yes
Secondary	Analysis of genes implicated in vitamin D metabolism		at inclusion.	Yes