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Sina Gallo¹, Kathryn Comeau¹, Catherine Vanstone¹, Sherry Agellon¹, Atul Sharma², Glenville Jones 3, Mary LAbbé 4, Ali Khamessan 5, Celia Rodd¹²*, Hope.

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Presentation on theme: "Sina Gallo¹, Kathryn Comeau¹, Catherine Vanstone¹, Sherry Agellon¹, Atul Sharma², Glenville Jones 3, Mary LAbbé 4, Ali Khamessan 5, Celia Rodd¹²*, Hope."— Presentation transcript:

1 Sina Gallo¹, Kathryn Comeau¹, Catherine Vanstone¹, Sherry Agellon¹, Atul Sharma², Glenville Jones 3, Mary LAbbé 4, Ali Khamessan 5, Celia Rodd¹²*, Hope Weiler¹* 1 School of Dietetics and Human Nutrition, McGill University, Montréal, Québec 2 Montreal Childrens Hospital, McGill University Health Centre, Montréal, Québec 3 Departments of Biomedical & Molecular Sciences & Medicine, Queens University, Kingston, Ontario 4 Department of Nutritional Sciences, University of Toronto, Toronto, Ontario 5 Euro-pharm International Canada Inc., Montréal, Québec *Senior authors Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: A randomized trial

2 Role of the Sponsor: The funding organizations had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. –Canadian Institutes of Health Research, Nutricia Research Foundation and the Canadian Foundation for Innovation –Fonds de la Recherche en Santé du Québec doctoral scholarship –The Canada Research Chairs professor salary award Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. AK is an employee of Europharm International Canada Inc. All other authors have no conflicts of interest. 2 Role of the Sponsor and Conflict of Interest Disclosures Role of the Sponsor and Conflict of Interest Disclosures

3 25(OH)D http://www.freedigitalphotos.net Mothers Skin 3 Maternal Sources: Sun, food and supplements Vitamin D Sources and Use: Infant Nutrition and Growth Vitamin D Sources and Use: Infant Nutrition and Growth

4 Infant Vitamin D Sources 25(OH)D CYP27A1 (liver) http://www.freedigitalphotos.net Mothers Skin 4 Maternal Sources: Sun, food and supplements Infant Sources: Maternal-fetal transfer, breast milk, supplements Vitamin D Sources and Use: Infant Nutrition and Growth Vitamin D Sources and Use: Infant Nutrition and Growth DBP Infant Vitamin D Stores

5 Infant Vitamin D Sources 25(OH)D CYP27A1 (liver) 1,25(OH) 2 D CYP27B1 (kidneys) Biologically Active http://www.freedigitalphotos.net Mothers Skin DBP 5 Maternal Sources: Sun, food and supplements Infant Sources: Maternal-fetal transfer, breast milk, supplements Vitamin D Sources and Use: Infant Nutrition and Growth Vitamin D Sources and Use: Infant Nutrition and Growth DBP Healthy bone growth Infant Vitamin D Stores

6 (International Units) 6 Prevention of Rickets and for Healthy Infant Growth Adequate Intake, Institute of Medicine USA; American Academy of Pediatrics Health Canada; Canadian Paediatric Society Canadian Paediatric Society Tolerable Upper Intake Level, Institute of Medicine USA No observed adverse effect level, Institute of Medicine USA Vitamin D Recommendations and Safety Levels: year 2006 http://www.freedigitalphotos.net Recommendations Safety Levels

7 25(OH)D concentrations (nmol/L) Oginni 1996 Graff 2004 (Nigeria) Dawodu 2005 (UAE) Garabedian 1983 (Belgium/France) Rickets Molla 2000 (Kuwait) Cesur 2003 (Turkey) Arnaud 1976 Severe(Canada/US) Arnaud 1976 Mild (Canada/US) Balasubraman 2003 (India) Canadian Paediatric Society Recommendation ---------------------------- Based on adults and older children; but unclear in infants. 7 Vitamin D Status based on Body Stores and Bone Health: year 2006

8 1.establish a vitamin D dosage which would support 25(OH)D concentrations 75 nmol/L in 97.5% of breast fed infants 50 nmol/L 2.further define the appropriate dosage using: weight, length and head circumference growth; the addition of mineral to growing bone. 8 Ethics: McGill University Institutional Review Board; Health Canada Clinical Trials; Trial Registration clinicaltrials.gov Identifier: NCT00381914. The study was conducted with the objectives to: 75 nmol/L = 30 ng/mL 50 nmol/L = 20 ng/mL

9 Randomized (n=132) 800 IU/d (n=39) 1600 IU/d (n=16) 400 IU/d (n=39) n=29 1200 IU/d (n=38) n=34 Follow-up 3 mo Follow-up 12 mo n=28 n=35n=32 n=29 n=15 n=12 Discontinued July 2008 - 81% of group pl. 25(OH)D >125 nmol/L after 2 mo Analyzed as intent-to-treat Did not meet criteria (n= 275) Contact declined or unavailable (n=185) Other reason (n=345) 74% retention 9 Study Groups: Healthy Infants Assessed for eligibility (n=937)

10 Visit 2 87% on vitamin D Birth 3 Age (months) Visit 4Visit 5Visit 6 6912 Recruitment Visit 3 21 Baseline Visit 1 Infants were randomized to receive 400, 800, 1200 or 1600 IU of vitamin D 3 daily Baseline Characteristics Mothers on average 33 y of age, 85% were white High income (60% > Canadian average $75,000) University educated mothers (89%) Infants (58% males) Born April-October (60%) Baseline Characteristics Mothers on average 33 y of age, 85% were white High income (60% > Canadian average $75,000) University educated mothers (89%) Infants (58% males) Born April-October (60%) 10 Trial Time Course http://www.freedigitalphotos.net

11 * p<0.01 vs. 400 IU/d at same time; logistic regression at each time point 11 How many infants met the vitamin D status target of 75 nmol/L of 25(OH)D? 3 months 800 vs 400 IU OR 3.5 95% CI, 1.1-11 1200 vs 400 IU OR 9.7 95% CI, 1.9-49.7

12 * p<0.01 vs. 400 IU/d at same time; logistic regression at each time point 12 How many infants met the vitamin D status target of 75 nmol/L of 25(OH)D? 3 months 800 vs 400 IU OR 3.5 95% CI, 1.1-11 1200 vs 400 IU OR 9.7 95% CI, 1.9-49.7

13 * p<0.01 vs. 400 IU/d at same time; logistic regression at each time point 13 How many infants met the vitamin D status target of 75 nmol/L of 25(OH)D? 3 months 800 vs 400 IU OR 3.5 95% CI, 1.1-11 1200 vs 400 IU OR 9.7 95% CI, 1.9-49.7

14 No differences among treatments over time by logistic regression at each time point 14 How many infants met the vitamin D status target of 50 nmol/L of 25(OH)D? Recommended Status Target IOM, AAP

15 Assessment of Growth Mean ± 95% CI; No differences among treatments over time by repeated measures ANOVA 15

16 Assessment of Bone Health Mean ± SEM; No differences among treatments over time by repeated measures ANOVA accounting for race after adjustment for multiple comparisons

17 400 IU dosage: sufficient to achieve 50 nmol/L of 25(OH)D; Higher dosages needed if target is 75 nmol/L of 25(OH)D; No further benefits to growth or bone health of infants. 17 Healthy Infant Nutrition: Public Policy & Position Statements for daily vitamin D supplementation dosages (International Units) Vitamin D Recommendations and Safety Levels: year 2013

18 400 IU dosage: sufficient to achieve 50 nmol/L of 25(OH)D; Higher dosages needed if target is 75 nmol/L of 25(OH)D; No further benefits to growth or bone health of infants. 6 to12 months Tolerable Upper Intake Level Institute of Medicine 18 Institute of Medicine Health Canada Canadian Paediatric Society American Academy of Pediatrics Canadian Paediatric Society Birth to 6 months Tolerable Upper Intake Level Institute of Medicine Healthy Infant Nutrition: Public Policy & Position Statements for daily vitamin D supplementation dosages (International Units) Vitamin D Recommendations and Safety Levels: year 2013

19 Identify status targets –Benefits to bone health Underpowered to detect early and longer-term benefits –Other health benefits Needs of other population groups –Underrepresented darker skin pigmentation –Higher risk for deficiency Remote geographic location Infant born with low vitamin D stores 19 Unanswered Questions: During and beyond infancy Unanswered Questions: During and beyond infancy

20 20 Leading Institutions Funding Agencies Recruitment and Monitoring Families and Infants Recruitment Five Pediatric Clinics West Island & Greater Montreal Area Lakeshore General Hospital Safety Officer Dr. J. Mitchell, M.D., F.R.C.P.C. This work was made possible by the following: http://www.freedigitalphotos.net


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