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

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.

Study Overview

• Status: Unknown
• Conditions: Bone Mineral Density in Cow's Milk Allergic Patients
• Intervention / Treatment: Behavioral: Active comparator; 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zerifin
    • Beer Yaakov, Zerifin, Israel, 70300
      • Recruiting
      • Asaf Harofeh Medical Center
      • Contact: Yitzhak Katz, MD; Phone Number: 972-8-9779820; Email: ykatz49@gmail.com
      • Principal Investigator: Yitzhak Katz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
efficacy of calcium supplemetation in preventing BMD loss in cow's milk allergic patients	2 years

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 25, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 187/11