Sprinkles Global Health Initiative
Frequently Asked Questions

Clinical
  1. Can Sprinkles be used to treat anemia or is it only used to prevent anemia?
  2. Can Sprinkles be used to treat vitamin D deficiency rickets?
  3. Should a person with thalassemia trait avoid iron supplements, such as iron-fortified vitamins or Sprinkles?
Use
  1. Aside from the 6-24 month age group bracket, can Sprinkles be used in infants younger than 6 months of age, older children, adolescents, adults and pregnant women?
  2. When should Sprinkles use be started and how long should Sprinkles be used?
  3. Can Sprinkles be used in fluids like milk or juice?
  4. Can Sprinkles be used in emergency rations?
  5. Can Sprinkles be used by Muslims and Jews who follow traditional food practices?
Side effects
  1. Why does stool consistency (loose stools or constipation) and colour change in infants when they start taking Sprinkles?
  2. Isn’t Sprinkles not supposed to change the taste and colour of the food? Why does this happen?
Toxicity
  1. Can Sprinkles be provided to non-anemic infants without producing any toxicity?
  2. Is vitamin A toxicity of concern for children, who receive both Sprinkles (containing vitamin A) and high dose vitamin A capsules twice yearly?
Supply
  1. Where can I get a supply of Sprinkles sachets?
  2. Who owns the intellectual rights to Sprinkles?
Miscellaneous
  1. Why were Sprinkles developed?
CLINICAL
1. Can Sprinkles be used to treat anemia or is it only used to prevent anemia?
Sprinkles can be used both in the treatment and prevention of anemia.

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2. Can Sprinkles be used to treat vitamin D deficiency rickets?
The vitamin D dose 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. The vitamin D dose in Sprinkles, however, is adequate to prevent rickets.

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3. Should a person with thalassemia trait avoid iron supplements, such as iron-fortified vitamins or Sprinkles?
Thalassemia and iron metabolism are closely linked. Iron deficiency and mild forms of thalassemia (e.g., thalassemia trait) are often confused. Both are associated with mild to moderate anemia and microcytosis (small red cells). At the other end of the spectrum, severe forms of thalassemia frequently produce iron overload. Excess iron accumulates due to a combination of enhanced iron absorption, repeated blood transfusions or both. People with thalassemia trait (thalassemia minor) are not at greater risk of complications from iron in the diet than anyone else in the general population. In the absence of concomitant iron deficiency, iron supplementation will neither correct nor improve anemia due to thalassemia. For people with both iron deficiency and thalassemia, iron replacement will lessen the severity of the anemia until the iron deficiency is corrected. The blood count will then level off and no further improvement will occur.

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USE
4. Aside from the 6-24 month age group bracket, can Sprinkles be used in infants younger than 6 months of age, older children, adolescents, adults and pregnant women?
Sprinkles was originally developed for infants and young children between 6-24 months of age. 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 a bottle with a dropper calibrated in milliliters. General food fortification, though suitable for preventing micronutrient deficiencies in the adult population, does not meet the micronutrient needs of young children, who ingest smaller amounts of food than adults.

Sprinkles occupy a unique niche for young children. We do not support or encourage the use of Sprinkles for infants under the age of six months as they should be exclusively breastfed in accordance with WHO guidelines on breastfeeding. For other age groups, more choices for supplementation are available, including the use of fortified foods, pills and capsules. Nevertheless, Sprinkles can be used in the other age groups without fear of toxicity. To date, our research emphasis has focused on infants and children under age 5; however, we also have ongoing research involving pregnant women.

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5. When should Sprinkles use begin and how long should Sprinkles be used?
The current recommendation from the World Health Organization (WHO) is that exclusive breastfeeding should last until 6 months of age. Afterwards, complementary feeding begins and Sprinkles can be given. Infants should receive 60 sachets consumed over 60 – 120 days. The provision of 60 sachets should be repeated every 6 months until a variety of mixed foods (containing iron and other micronutrients) are being eaten.

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6. Can Sprinkles be used with fluids like milk or juice?
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. Although Sprinkles can be used with any fluid, some will be lost in the process.

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7. Can Sprinkles be used in emergency rations?
Sprinkles is safe to use and recommended to improve micronutrient status in emergency situations. Emergency rations tend to include corn-soya blend (CSB) or wheat-soya 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. A research study in rural Haiti showed a decrease of anemia prevalence by one-half when Sprinkles was used with WSB, while anemia prevalence increased when WSB was used alone. Sprinkles has been used in emergency relief aid in countries like Indonesia and Haiti.

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8. Can Sprinkles be used by Muslims and Jews who follow traditional food practices?
Yes. Neither alcohol nor porcine 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.

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SIDE EFFECTS
9. Why does stool consistency (loose stools or constipation) and colour change in infants when they start taking Sprinkles?
Stool consistency does not change in the majority of infants and children receiving Sprinkles. Stool colour, however, changes to a dark or black colour in all infants receiving Sprinkles on a regular basis. Iron itself is dark in colour. When some quantities are left unabsorbed, the iron is excreted in the stool and causes the change in colour. 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 lasts for approximately one week and then will not recur. Parents have reported that diarrhea quickly disappears in these young infants, who are transitioning from breastfeeding to complementary feeding, if 1/3 - 1/2 of a Sprinkles sachet is used.

Loose stools may be caused by a change in bowel flora (microorganisms) 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 loose stools have only been observed in infants transitioning from exclusive breastfeeding to complementary feeding, loose stools may possibly be unrelated to Sprinkles, and instead related to the change in stool pattern with the introduction of complementary foods.

Likely, the microencapsulation of iron and presence of food during Sprinkles intake accounts for the fewer and less severe cases of diarrhea and constipation than other iron supplements.

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10. Isn’t Sprinkles not supposed to change the taste and colour of food? Why does this happen?
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 hotter than 60ºC, the lipid coating around the iron will melt and the food will be exposed to the iron. The iron can then change the colour of the food and will certainly have a strong taste.

To prevent changes in the taste and colour of food to which Sprinkles is added, we recommend that Sprinkles be added to food after it is cooled to a temperature below 60ºC.

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TOXICITY
11. Can Sprinkles be provided to non-anemic infants without producing any toxicity?
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, a 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 remained within 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.

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12. Is vitamin A toxicity of concern for children, who receive both Sprinkles (containing vitamin A) and high dose vitamin A capsules twice yearly?
There is no risk of toxicity. Sprinkles containing vitamin A is formulated to help children meet their daily vitamin A requirement (the Recommended Daily Allowance or RDA). It is safe to use the two supplements together because Sprinkles use is complementary to high dose vitamin A capsules and not competitive. With the distribution of high dose capsules, the WHO recommends an age-appropriate diet which would contain all micronutrients, including vitamin A.
SUPPLY
13. Where can I get a supply of Sprinkles sachets?
Unfortunately SGHI does not supply Sprinkles. We were directly involved in the manufacturing process during the clinical trial and pilot program stages when there was no commercial supply available, but we have now reverted fully to our primary roles of advocacy, clinical research and implementation research relating to Sprinkles and other nutritional interventions. We can, however, suggest where you can obtain a supply of Sprinkles.

We are also no longer involved in monitoring the quality control of sprinkles products, however, we encourage sprinkles suppliers and distributors to regularly monitor product quality to ensure the safety and efficacy of sprinkles products for end users.

Sprinkles is not available in North America.

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14. Who owns the intellectual rights to Sprinkles?
SGHI controls the Canadian and American patent rights for the invention known and trade marked as Sprinkles®. These patent rights effectively extend to any micro-nutrient formulations which include micro-encapsulated iron and which are contained in single-dosage sachets, or other forms of packages which enable the user to sprinkle the formulation onto prepared foods. Therefore, the manufacture, distribution and/or marketing of such products in Canada and the United States of America are not allowed without SGHI’s express, written permission.

Sprinkles® is not patented in the rest of the world. In September 2007, SGHI and its sponsor, the Heinz Foundation, formally announced that they were putting the Technical Specifications for the Sprinkles® products into the public domain outside of Canada and the United States of America. This announcement was made at a meeting attended by such organizations the Global Alliance for Improved Nutrition (GAIN), the Micronutrient Initiative (MI), UNICEF, USAID, and WFP. The Technical Specifications include information on formulations, ingredients, and packaging materials. Thus, manufacturers who are able to prove their commitment to quality control can now approach SGHI, or organizations such as GAIN, for these Technical Specifications.

Please note that this open access does not extend to SGHI’s global trade mark rights to the brands Sprinkles, Sprinkles Plus, SuppleFer, and SuppleFem. These brands cannot be associated with any micro-nutrient powder product without SGHI’s express, written permission, which will be granted only if SGHI is absolutely confident that the quality of the product meets or exceeds the standards set out in the Technical Specifications at all times.
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MISCELLANEOUS
15. Why were Sprinkles developed?
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. The Sprinkles concept 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 Sprinkles Global Health Initiative at The Hospital for Sick Children, University of Toronto, developed Sprinkles utilizing encapsulated iron that could be added directly to food.

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