Young Adults With Life Threatening Cow's Milk Allergy: Risks of Decrease Bone Mineralization and Methods of Calcium Supplementation
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|ClinicalTrials.gov Identifier: NCT01930266|
Recruitment Status : Unknown
Verified August 2013 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : August 28, 2013
Last Update Posted : August 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Mineral Density in Cow's Milk Allergic Patients||Dietary Supplement: Experimental Behavioral: Active comparator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
No Intervention: Observational
Patients will receive general dietary instructions with an annual follow-up. At this follow up, a repeat BMD, dietary and laboratory evaluation will be performed.
Active Comparator: Interventional.
Patients will receive detailed dietary instructions with periodic (3 month) follow up. At the follow-up patients will be assessed whether they reached their calcium intake goals both quantitatively and whether appropriate calcium sources were utilized.
Behavioral: Active comparator
Experimental: Active interventional
Patients will receive detailed dietary instructions and active follow up with diary and email reports. Inclusion in group C will be predicated upon intake of 100% DRI of calcium primarily by food sources, with the addition of Calcium Carbonate 600 mg, if necessary
Dietary Supplement: Experimental
- efficacy of calcium supplemetation in preventing BMD loss in cow's milk allergic patients [ Time Frame: 2 years ]
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): NCT01930266
|Contact: Yitzhak Katz, MDfirstname.lastname@example.org|
|Asaf Harofeh Medical Center||Recruiting|
|Beer Yaakov, Zerifin, Israel, 70300|
|Contact: Yitzhak Katz, MD 972-8-9779820 email@example.com|
|Principal Investigator: Yitzhak Katz, MD|