Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT01930266
Status:
UNKNOWN
Last Update Posted:
2013-08-28
First Post:
2013-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Young Adults With Life Threatening Cow's Milk Allergy: Risks of Decrease Bone Mineralization and Methods of Calcium Supplementation
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diet is the only source for calcium and the most important dietary source are dairy products. This presents a difficulty for children with IgE-mediated cow's milk allergy, who are unable to consume milk. We noted that IgE-CMA allergic young adults have a significant decrease in bone mineral density (BMD) compared to international reference values and also to geographically and age matched normal controls.
Working hypothesis: Young adults with IgE-CMA have significantly lower BMD than age and gender matched controls. This can be reversed by introducing dairy products following recovery from allergy, or by enriching the diet via other calcium sources.
Working hypothesis: Young adults with IgE-CMA have significantly lower BMD than age and gender matched controls. This can be reversed by introducing dairy products following recovery from allergy, or by enriching the diet via other calcium sources.
Detailed Description:
The aims of the study are 1. To study the prevalence and severity of reduced BMD among IgE-CMA allergy patients 2. to estimate the potential of recovery from reduced BMD after administration of milk during oral immunotherapy.
3\. To determine the efficacy of intervention with other (non-dairy) calcium enriched diets in IgE-CMA young adults, utilizing several methods to direct compliance.
Methods: We will study the bone mineral content (BMC), BMD, serum values of bone turnover factor, dietary and lifestyle questionnaires of 150 post pubertal IgE-CMA patients with no history of dairy consumption and 150 age and gender matched normal controls. Separately, we will compare the above values of these patients to those of former IgE-CMA patients who now ingest milk after recovery from allergy. Finally, we will examine the effects of including non-dairy dietary sources of calcium in IgE-CMA patients, with different groups receiving different degrees of interventional guidance.
The study will provide insight into the bone health of CMA patients, and provide guidance as to effective dietary treatments and its implementation. Furthermore, important nutritional data on the best methods for intervention to reduce osteoporosis will likely be learnt, that should have far reaching ramifications, not only to this particular population, but to osteoporosis patients, at large.
3\. To determine the efficacy of intervention with other (non-dairy) calcium enriched diets in IgE-CMA young adults, utilizing several methods to direct compliance.
Methods: We will study the bone mineral content (BMC), BMD, serum values of bone turnover factor, dietary and lifestyle questionnaires of 150 post pubertal IgE-CMA patients with no history of dairy consumption and 150 age and gender matched normal controls. Separately, we will compare the above values of these patients to those of former IgE-CMA patients who now ingest milk after recovery from allergy. Finally, we will examine the effects of including non-dairy dietary sources of calcium in IgE-CMA patients, with different groups receiving different degrees of interventional guidance.
The study will provide insight into the bone health of CMA patients, and provide guidance as to effective dietary treatments and its implementation. Furthermore, important nutritional data on the best methods for intervention to reduce osteoporosis will likely be learnt, that should have far reaching ramifications, not only to this particular population, but to osteoporosis patients, at large.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: