1. Question: For children who are receiving high dose vitamin A capsules twice yearly, is there any concern about vitamin A toxicity if they also receive Sprinkles, which also contain vitamin A?
Answer: There is no risk of toxicity. The dose of vitamin A in Sprinkles is formulated to help the child meet the daily vitamin A requirement (the RDA). As such, the use of Sprinkles as ‘home fortification’ is complementary to the high dose vitamin A capsules, not competitive. When the WHO initiated the high dose capsules, they did not stipulate that the child receiving the supplement should not eat food containing vitamin A. Indeed they recommended an age-appropriate diet which would contain all micronutrients, including vitamin A. Sprinkles with vitamin A is formulated to help the child meet their RDA for vitamin A and thus is safe to use with the high dose supplement.
2. Question: It has been noted that some infants develop a change in their stool consistency (diarrhea or constipation) and colour when they start taking Sprinkles. Why does this happen? Is it of any significance?
Answer: In the majority of infants and children receiving Sprinkles, there will not be a change in the consistency of their stools. The colour of the stool will change to a dark or black colour in all infants if they are receiving the Sprinkles on a regular basis. The dark colour is a result of the ‘unabsorbed’ iron being excreted in the stool. Iron itself is dark in colour, thus unabsorbed iron will darken the stool.
Some very young infants, who have not previously been exposed to any complementary foods containing micronutrients (i.e. who are exclusively breast-fed) may develop loose stools or even mild diarrhea. The diarrhea does not lead to dehydration, but is a valid concern to parents and health care providers. The diarrhea seems to last for about a week and then will not recur. Parents have reported to us that if they use 1/3 – 1/2 of a package of Sprinkles added to complementary foods in young infants who are starting the transition from breastfeeding to complimentary feeding, the diarrhea quickly disappears. Others use 1/3 of a package at each meal with similar outcomes.
We are not sure about the etiology of the diarrhea, but it may be due to the change in bowel flora associated with the introduction of iron into the diet or possibly the impact of ascorbic acid on bowel peristalsis in infants who previously had received only very small amounts of ascorbic acid in their diets (in breast milk).
Since the diarrhea has only been observed in infants when they are beginning the process of transition from exclusive breast feeding to a diet of complementary feeds, it is possible that the diarrhea is unrelated to the Sprinkles, but is more related to the change in stool pattern with the early introduction of complementary foods.
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3. Question: Can Sprinkles be used in fluid drinks like milk or juice?
Answer: Sprinkles can be used in any food products, but because the iron is coated with lipid (to mask the metallic taste), it will float to the top of liquids and tend to stick to the side of the cup or glass. So, although Sprinkles can be used with any fluid, some will be lost in the process.
4. Question: Can Sprinkles be provided to non-anemic infants without producing any toxicity?
Answer: Yes. The amount of micronutrients in the Sprinkles sachets is high enough to meet the needs of infants with micronutrient deficiencies (e.g. iron deficiency anemia) but not too high for those who do not have deficiencies. We have completed a research study in China with 400 preschool children, the majority of whom were non-anemic (95%). Sprinkles prevented anemia (when provided for 4 months) with absolutely no evidence of excessive iron stores. Serum ferritin values remain in the normal range in 100% of infants included in the study.
Thus Sprinkles are safe to use, even in infants without micronutrient deficiencies. In fact, Sprinkles were originally designed to prevent deficiencies in non-deficient children at risk of micronutrient deficiencies.
5. Question: Sprinkles are recommended to be used in children between 6 – 36 months of age. Can they be used in older children, adolescents, adults and pregnant women?
Answer: Yes, they can be safely used for any age group, although they were developed for infants and young children. Infants and young children cannot safely ingest tablets or pills. Syrups and drops have been used for many years, but compliance has been documented to be poor (for iron) because of the strong unpleasant taste of the drops; the drops tend to stain the teeth unless they are carefully placed at the back of the infants’ mouth; and for parents who cannot read, it is often difficult to measure the appropriate amount of liquid iron which is often supplied in bottle with a dropper calibrated in milliliters. In addition, although general food fortification is an excellent way to prevent micronutrient deficiencies in adults, because children ingest smaller amounts of foods than do adults, general fortification often will not meet the micronutrient needs of young children. Thus for children, Sprinkles occupies a unique niche for this age group. For other age groups, there are more choices for supplementation, including the use of fortified foods, pills and capsules. Nevertheless, Sprinkles can be used in these other age groups without fear of toxicity.
To date, our research emphasis has focused on infants and children under aged 5 years. So, other than anecdotal reports involving individual adults and adolescents with anemia, we do not have formal efficacy results for other age groups.
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6. Question: Can Sprinkles be used to treat vitamin D deficiency rickets?
Answer: The dose of vitamin D in Sprinkles is meant to meet the RDA for vitamin D, rather than provide a therapeutic intervention. Thus, for rickets treatment, the recommended dose of vitamin D is significantly higher than the dose present in Sprinkles. However the dose of vitamin D in Sprinkles is adequate to prevent rickets.
7. Question: Can Sprinkles be used to treat anemia or is it only appropriate as a means of preventing anemia?
Answer: Sprinkles can be used both in the treatment and prevention of anemia. For those who have known anemia, it may be appropriate to use 2 – 3 sachets of Sprinkles per day to treat the anemia. For the prevention of anemia, 1 sachet per day has been found to be adequate.
8. Question: Sprinkles has been put forward as a home fortificant that will not change the taste or colour of the food into which it is added. However, some parents have noticed a change in the taste and colour of the food. Can this be explained?
Answer: In order to mask the strong metallic taste of the iron, the iron in the Sprinkles is coated or encapsulated with a thin coat of a soy lipid. The melting temperature for the lipid is around 60oC. If Sprinkles are added to food that is hotter than 60oC, the lipid coating around the iron will melt and the iron will be exposed to the food. The result will be that the iron can change the colour of the food and certainly will have a strong taste.
To prevent changes in the taste and the colour of food to which Sprinkles is added, we recommend that Sprinkles be added to the food after it is cooled to a temperature below 60oC.
9. Question: What is the cost of Sprinkles and are they readily available to the general public?
Answer: The cost of producing Sprinkles is between 3 – 5 cents per sachet depending on the volume that is produced. Currently there is no commercial source of Sprinkles, however, Sprinkles are available for use by governments, U.N. agencies and non-governmental organizations who will provide Sprinkles on a humanitarian basis to populations in need.
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10. Question: Who owns the intellectual rights to Sprinkles?
Answer: The intellectual property rights to Sprinkles are owned by Ped Med Ltd., a private incorporated company owned by Stanley Zlotkin. In 1998, The Hospital for Sick Children turned down the rights to the Sprinkles. Consequently, the rights were taken up by Dr. Zlotkin. Our group has an agreement with the H.J. Heinz company such that they will provide technical support, assist in the manufacture of Sprinkles from various manufacturing facilities around the world and produce the Sprinkles on a ‘cost-recovery’ basis for research and humanitarian purposes. This is a humanitarian effort by the Heinz company and is meant to aid us in large-scale manufacturing of the Sprinkles as part of large studies or programs. At some point in the future, Sprinkles may be produced commercially. At this time, Heinz will be offered the “right of first refusal” to develop, manufacture and market a fully commercial product with appropriate pricing and margin, to ensure consumer acceptance and commercial viability. Under these circumstances, at our discretion, and subject to agreement with the manufacturer, Ped Med Ltd. may receive a royalty for license of the Sprinkles technology. However, our goal is to ensure that a segment of the manufacturing of Sprinkles may still remain “at cost” to target vulnerable populations through non-governmental organizations or larger government organizations such as UNICEF.
11. Question: How long should Sprinkles be used? When should they be started?
Answer: The optimum duration of supplementation is yet to be determined. However, use of Sprinkles for a period of 6-months is most reasonable. We have seen increases in hemoglobin after two months of supplementation in our Ghana study, where 58% of anemic infants became non-anemic by the end of the intervention. In addition, all infants in the First Nations and Inuit study who were anemic became non-anemic after 3 months of supplementation with Sprinkles. It is not clear, however how long the intervention period should be. Therefore, we will be conducting studies to compare various durations of supplementation to determine the optimum intervention period.
The current recommendation from the World Health Organization (WHO) is that exclusive breastfeeding should last until 6 months of age. Sprinkles may be given once complementary foods are being given.
12. Question: Why were Sprinkles developed?
Answer: In 1996, a group of UNICEF consultants determined that the standard iron drops were not effective, as adherence to treatment remained poor. They called for a simple, inexpensive and potentially viable new method to provide micronutrients (including iron) to populations at risk (UNICEF-monograph). This was based on two observations from the ‘West’ where micronutrient deficiencies are rare; (a) fortification of commercially available food provides essential micronutrients and (b) no change in the color, texture or taste of the food ensures compliance.
Responding to the challenge, the Nutrition Research Group at The Hospital for Sick Children, University of Toronto, developed ‘Supplefer’ Sprinkles utilizing encapsulated micronutrients for adding directly to food, that is inexpensive to manufacture and distribute.
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13. Question: Can Sprinkles be used in emergency rations?
Answer: Sprinkles can be added to any semi-solid complementary food. Emergency rations tend to include corn-soy blend (CSB) or wheat-soy blend (WSB), two vehicles suitable for the addition of Sprinkles. Both these rations produce a thick paste-like substance after cooking, to which Sprinkles may be added after cooling to provide an additional source of micronutrients.
14. Question: Can Sprinkles be used by Muslims and Jews who follow traditional food practices?
Answer: No alcohol or pork products are used in the production of Sprinkles. They are therefore both Halal and Kosher and may be used as part of a traditional Muslim or Jewish diet.
15. Question: Can Sprinkles be used in infants younger than 6 months of age.
Answer: Sprinkles may be used in children under 6 months of age where complementary foods are being given. However, due to the WHO recommendation that infants be exclusively breastfed until 6 months of age, we do not recommend using Sprinkles before 6 months in case it encourages caregivers to end exclusive breastfeeding before 6 months.