Status:
COMPLETED
Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Danone Global Research & Innovation Center
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
PHASE3
Brief Summary
This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to investigate whether oral milk protein supplements led to increase in serum Insulin-like Growth Factor-I levels (I...
Detailed Description
Study centres: 4 active centres in France and 2 active centres in Switzerland
Eligibility Criteria
Inclusion
- Women aged between 18 to 40 years (bounds included).
- Women with a serum IGF-I level below the 25th percentile of the reference value according to the age (bounds included).
- Women who had given written inform consent.
- Women with DSM-IV-confirmed anorexia nervosa lasting for at least 6 months. Women with concomitant binge eating and purging type are also included.
- Women admitted in-hospital for weight and nutritional rehabilitation. It is anticipated that the patient will stay in-hospital during the full duration of the 4-week supplementation phase, and at least 5 weeks within the study.
- Women being already regular consumers of dairy products.
- For women with childbearing potential, use of a contraceptive method.
- Discontinuation of any mineral and vitamin supplements containing calcium and vitamin D, 1 week before starting the product consumption and during the study.
Exclusion
- Women with primary amenorrhea;
- Women with lactose intolerance;
- Women with any other metabolic disease that could affect bone metabolism: osteogenesis imperfecta, Paget's disease of bone, hyperthyroidism, primary hyperparathyroidism;
- Women with current or past neoplasm;
- Women with any other severe comorbidity;
- Pregnant or breast feeding women;
- Women with epilepsy;
- Women with any current or past use of the following treatments: bisphosphonates, calcitonin, steroids;
- Patients enrolled in another clinical study within the last 4 weeks;
- Patients having already received oral nutritional supplements or who need to receive other oral or intravenous (IV) supplements during the follow-up;
- Patients having received oral or IV nutritional supplements within two weeks before the inclusion;
- Patients having willed to participate in another clinical study during the present study phase and 4 weeks after the end of their participation in the present study.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01823822
Start Date
June 1 2008
End Date
April 1 2009
Last Update
April 4 2013
Active Locations (1)
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1
Bone Diseases Service, Geneva University Hospitals
Geneva, Switzerland