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

NCT01930266 | Unknown DMC

• 1 other identifier: 187/11
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Mineral Density in Cow's Milk Allergic Patients

Outcome Measures

Primary Outcomes (1)

• efficacy of calcium supplemetation in preventing BMD loss in cow's milk allergic patients

  2 years

Study Arms (3)

Observational

NO INTERVENTION

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.

Interventional.

ACTIVE COMPARATOR

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

Active interventional

EXPERIMENTAL

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

Interventions

Experimental DIETARY_SUPPLEMENT

Active interventional

Active comparator BEHAVIORAL

Interventional.

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Asaf Harofeh Medical Center

Beer Yaakov, Zerifin, 70300, Israel

RECRUITING

Central Study Contacts

Yitzhak Katz, MD

CONTACT

972-8-9779820; ykatz49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helsinki commitee

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: August 28, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

IL (1)