Bone Mineral Density in Cow's Milk Allergic Patients Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention