Vitamin D levels in children optimized with six Vitamin D biscuits – RCT

Created October 2019

Stoss therapy using fortified biscuit for vitamin D-deficient children: a novel treatment.

Pediatr Res. 2018 Nov;84(5):662-667. doi: 10.1038/s41390-018-0135-4

Children were aged 30-72 months 3 RCT groups: Biscuit, capsule and injection 50,000 IU biscuits were given twice a week for 3 weeks --- Items in both categories Loading Dose and Infant-Child are listed here: {category} Items in both categories Intervenetion non-daily and Infant-Child are listed here: {category}

Moslemi L1, Esmaeili Dooki M2, Moghadamnia AA3, Aghamaleki MA1, Pornasrollah M1, Ashrafianamiri H4, Nooreddini HG1, Kazemi S5, Pouramir M5, Bijani A4.

  • 1 Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Mazandran, Iran.

  • 2 Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Mazandran, Iran. esmaeilidooki@yahoo.com.

  • 3 Department of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences, Babol, Iran.

  • 4 Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Mazandran, Iran.

  • 5 Cellular and Molecular Biology Research Center, Health Research Center, Babol University of Medical Sciences, Babol, Mazandran, Iran.

BACKGROUND:To evaluate the efficacy of stoss therapy using fortified biscuit for vitamin D-deficient children.

METHODS:

A total of 108 children aged 30-72 months with vitamin D deficiency were studied in a randomized single-blind clinical trial. The deficient children were assigned to three groups, namely, vitamin D-fortified biscuit (BG), capsule vitamin D (CG), and ampoule vitamin D (AG). Capsules and biscuits containing 50,000 IU of cholecalciferol were consumed twice per week for 3 consecutive weeks. Ampoules with 300,000 IU of cholecalciferol were injected intramuscularly in a single dose. Three weeks after treatment, serum 25(OH)D concentrations were measured, and the three groups were compared.

RESULTS:

Each method of treatment could increase the mean serum 25(OH)D concentration to optimal level. Serum 25(OH)D concentrations ≥100 ng/mL were observed in six children, including four from AG and two from CG (P = 0.09). The comparison of the mean serum 25(OH)D concentrations after treatment showed between ampoule and capsule (P = 0.3) and capsule and biscuit (P = 0.62) were insignificant; however, the ampoule and biscuit groups differed significantly (P = 0.012).

CONCLUSION:

Stoss therapy using fortified biscuit may be an effective way to improve compliance in children who cannot take capsules without adverse effects and may also be recommended for prevention purposes.

Tags: Infant-Child Intervention Intervention - non daily Loading dose