Schlagwort-Archive: clinical trial

Primary prevention of cow’s milk sensitization and food allergy by avoiding supplementation

A new study by Urashima et al. shows that sensitization to cow’s milk and food allergy, including CMA and anaphylaxis, is preventable by avoiding CMF (cow milk formula) supplementation for at least the first few days of life. Although examined only indirectly in this study, vitamin D supplementation seems to be involved in the sensitization process.

Note to self – this is now study no 5 of vitamin D related clinical trials on allergy
1. De Montis G, Gendrel D, Chemillier-Truong M, Dupont C. Sensitisation to peanut and vitamin D oily preparations. The Lancet 1993;341(8857):1411.6.
2. Norizoe C, Akiyama N, Segawa T, Tachimoto H, Mezawa H, Ida H, Urashima M. Increased food allergy with vitamin D: A randomized, double-blind, placebo-controlled trial. Pediatr Int 2014; 56:6-12.7.
3. Rueter K, Jones AP, Siafarikas A, Lim EM, Bear N, Noakes PS, et al. Direct infant UV light exposure is associated with eczema and immune development. J Allergy Clin Immunol 2018; in press, doi: 10.1016/j.jaci.2018.08.037.
4. Rosendahl J, Pelkonen AS, Helve O, et al. . High-Dose Vitamin D Supplementation Does Not Prevent Allergic Sensitization of Infants. J Pediatr. 2019 Jun;209:139-145.e1. doi: 10.1016/j.jpeds.2019.02.021
5. Urashima M, Mezawa H, Okuyama M, et al. Primary Prevention of Cow’s Milk Sensitization and Food Allergy by Avoiding Supplementation With Cow’s Milk Formula at Birth. JAMA Pediatr. 2019;173(12):1137-1145. doi:10.1001/jamapediatrics.2019.3544

The Urashima study is accompanied by a valuable editorial of George du Toit and Kari Nadeau

There is currently a lack of consensus among national allergy societies .. Although the EAACI3 and American Academy of Allergy, Asthma and Immunology (AAAI) currently recommend the use of hypoallergenic formulas in infants at high risk of allergy, the Australian Society of Clinical Immunology and Allergy does not. The EAACI and the AAAI are likely to reconsider their guidelines because results of more re- cent studies have been contradictory. …
Guidelines in the United States and United Kingdom recommend routine vitamin D supplementation in all breastfed infants, whereas guidelines in Australia recommend supplementation only in breastfed infants at high risk of vitamin D insufficiency.

The first proven risk factor for allergy

After more than a century of research, the first successful clinical trial of an allergy risk factor has been performed. It looks like the authors even did not anticipate such an effect (known as triple blind design). But read what the Pubmed article about the Norizoe et al. paper says

To elucidate whether maternal vitamin D supplementation during lactation improves infantile eczema and other subsequent allergic disorders, a randomized, double-blind, placebo-controlled trial was performed.
Mothers (n=164) of infants with facial eczema at one-month checkup were randomly assigned to receive vitamin D3 supplements (n=82; 800 IU/day) or placebo (n=82) for 6 weeks from May 2009 to January 2011. The primary outcome was infantile eczema quantified by Scoring Atopic Dermatitis (SCORAD) index at the three-month checkup, and the secondary outcomes were atopic dermatitis, food allergy, and wheeze diagnosed by doctors up to 2 years of age.
There was no significant difference in SCORAD at 3-month checkup between two comparative groups. Doctor-diagnosed food allergy was significantly more common up to age 2 years in vitamin D group (10/39: 25.7%) than in placebo group (3/40: 7.5%; RR=3.42, 95%CI=1.02 to 11.77, P=0.030). Moreover, at least one secondary outcome was also significantly more common in vitamin D group (17/39: 43.6%) than in placebo group (7/40: 17.5%; RR=2.49, 95%CI=1.16 to 5.34, P=0.012).
These results suggest that vitamin D supplementation may not decrease the severity of infantile eczema at three months of age, but may rather increase the risk of later food allergy up to two years of age. Because a large number of subjects was lost to follow-up, further study is needed to confirm the findings.

Of course, there may be some weakness in the study design, a large loss to follow-up and the way how food allergy was diagnosed will be critized. I think, however, that this is a major breakthrough that raises the hope that we will finally understand how allergy develops.

Addendum Dec 23th, 2013

I should have added “true” risk factor, as there are positive trials on probiotics and atopic dermatitis. The meta-analysis by Lee immediately lead to a rebuttal

Their review fails to meet published standards for the quality of systematic reviews on several criteria, and this has led to inappropriate conclusions. […] These defects in methodologic rigor have led to an exaggeration of the clinical benefits of probiotics for eczema prevention.

The Cochrane Summaries are also negativ

There is not enough evidence to recommend using probiotics for the treatment of eczema.

Same situation with asthma

We found no evidence to support a protective association between perinatal use of probiotics and doctor diagnosed asthma or childhood wheeze

A catholic view of science

Following the protestantic view of science here are some thoughts that I found in the new book by Benedetto XVI aka Joseph Ratzinger “Jesus von Nazareth”. Rationality as divine gift? Yes, Benedict follows the Historical Critical Method but wants to reconcile it with revelation that is not accessible to logical arguments. While it is not a book on science A catholic view of science weiterlesen