Young Adults With Life Threatening Cow's Milk Allergy: Risks of Decrease Bone Mineralization and Methods of Calcium Supplementation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01930266
First received: August 25, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention
Bone Mineral Density in Cow's Milk Allergic Patients
Dietary Supplement: Experimental
Behavioral: Active comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • efficacy of calcium supplemetation in preventing BMD loss in cow's milk allergic patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All post pubertal males and females diagnosed with IgE-mediated CMP allergy were eligible Puberty in both sexes was determined by signs of Tanner stage IV. Females were at least two years after menarche The minimal age for girls was 16 years and for boys 17.5 years old. The maximal age to be included in this study was 30 years old

Exclusion Criteria:

female's history of pregnancy, and in both genders any 128 bone affecting disease/treatment, systemic steroid treatment for a period longer than 4 weeks or multiple short courses of systemic steroid treatments.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930266

Contacts
Contact: Yitzhak Katz, MD 972-8-9779820 ykatz49@gmail.com

Locations
Israel
Asaf Harofeh Medical Center Recruiting
Beer Yaakov, Zerifin, Israel, 70300
Contact: Yitzhak Katz, MD    972-8-9779820    ykatz49@gmail.com   
Principal Investigator: Yitzhak Katz, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Assaf Harofeh MC, Helsinki commitee, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01930266     History of Changes
Other Study ID Numbers: 187/11
Study First Received: August 25, 2013
Last Updated: August 27, 2013
Health Authority: Israel: Ethics Commission

ClinicalTrials.gov processed this record on August 01, 2014