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Vitamin D Dose Response Study

RESULTS PUPLISHED!

jama_article_vitamin_d.pdf

 

Information for Parents

We are currently recruiting healthy newborn infants and their mothers to participate a study on vitamin D supplements for babies during their first year of life.
We welcome you to read through the information as well as the consent form which provides all the details about the study.

Why are we doing this study?

Vitamin D plays a very important part in keeping your baby healthy but recent research tells us that 20-80 % of Canadian infants do not get enough vitamin D. This study is being done to figure out the best possible vitamin D dose for infants.

Why is vitamin D important for infants?

Vitamin D is needed for the growth of strong healthy bones. It may also protect against the development of other diseases such as diabetes and cancer. Breast milk contains very little vitamin D and pediatricians typically recommend babies get a liquid vitamin D supplement. Health Canada recommends that all breastfed infants receive a vitamin D supplement each day to maintain health. Many researchers believe that this dose is too low because of the number of babies with rickets and vitamin D deficiency in Canada.

Do you and your infant fit the study criteria?

 Healthy infant born at term (37-42 weeks gestation)
 Breastfeeding
 No gestational diabetes or hypertension (mother)

What is involved in participating?

The study begins when your infant is one month old and continues until he/she is one year old. We will give you vitamin D drops for your baby to take each day. We will need to see you six times over the year (1, 2, 3, 6, 9 and 12 months of age) to collect :
 Body measurements of both mother and infant
 Dietary questionnaires
 Breast milk samples
 Urine samples from infant
 Bone density test of the infant
 Assesment of Vitamin D levels (done by poking the heel or finger of the infant and collecting 1ml of blood)

The 2 month visit will only include only the urine and blood sample components.

A note about blood testing

The small amount of blood we collect at each visit (less than a fifth of a teaspoon) is collected from either the heel of very small babies or the finger of older babies. We follow very specific procedures to ensure that you baby is as comfortable as possible. While there is an initial sting, babies are generally very calm through this procedure, often sleeping through it.

A note about bone density testing

In this study we are using Dual Energy X-Ray Absorptiometry or DXA technology to determine the density and mineral composition of your baby's bones. This test takes only a few minutes. We wait until your infant falls asleep, placing them on the bed of our machine. The arm of the machine then passes over them, giving us an image of their bones. While this machine does use X-rays, the effective dose of these X-rays is very small. In fact, the dose is so low that unlike X-rays your child might receive for a broken arm or a chest infection, you will be able to stay in the room beside your infant.

To view additional background information on DXA technology used for bone scanning, click the thumbnail below

Thumbnail DXA factsheet

The Front Door of MECNRU

Where do the visits take place?

All study visits take place at the Mary Emily Clinical Nutrition Research Unit of McGill University in Ste. Anne de Bellevue. This beautiful house has been converted to a nutrition clinic which offers a welcoming and warm environment for participating families. Parking is available free of charge.

Vitamin D Supplements

Europharm Logo Dr. Ali Khamessan (Ph.D., Director, C-Crest Laboratories Inc.) at Euro-Pharm International Canada has partnered with our research team for this project. Vitamin D supplements in three concentrations (400IU, 800IU, 1200IU) have been specially designed for this dose-response study.

A label from the Vitamin D supplement used in this study

View the consent form for this study in English or French:

 

How to Join

Interested parents should contact Catherine or Sina for more information.