Nutr Res Pract.  2020 Apr;14(2):117-126. 10.4162/nrp.2020.14.2.117.

Occurrence of infections in schoolchildren subsequent to supplementation with vitamin D-calcium or zinc: a randomized, double-blind, placebo-controlled trial

• Mandlik R
• Mughal Z
• Khadilkar
• Chiplonkar S
• Ekbote V
• Kajale N
• Patwardhan V
• Padidela R
• Khadilkar

• KMID: 2471879
• DOI: http://doi.org/10.4162/nrp.2020.14.2.117

Abstract

BACKGROUND/OBJECTIVES
Vitamin D and zinc are recognized for their roles in immune-modulation, and their deficiencies are suggested to be important risk factors for childhood infections. This study, therefore, undertook to assess the occurrence of infections in rural Indian schoolchildren, subsequent to daily supplementation with vitamin D-calcium or zinc for 6 months.
MATERIALS/METHODS
This was a randomized, double-blind, placebo-controlled trial in apparently healthy 6-12 year-old rural Indian children, recruited to 3 study arms: vitamin D arm (1,000 IU D3 - 500 mg calcium, n = 135), zinc arm (10 mg, n = 150) and placebo arm (n = 150). The infection status was assessed using a validated questionnaire, and the biochemical parameters of serum 25(OH)D and serum zinc were measured by ELISA and colorimetry, respectively. The primary outcome variable was occurrence of infections (upper respiratory and total infections).
RESULTS
Serum 25(OH)D concentration in the vitamin D arm improved significantly by 34%, from 59.7 ± 10.9 nmol/L to 80 ± 23.3 nmol/L (P < 0.0001), but no improvement was observed for serum zinc concentration. While there was significant increase in the percentage of children reporting no or mild upper respiratory tract infections (URTI) and total infections (TI) in all three groups, improvements in the supplemented groups were similar to the placebo group. However, the vitamin D arm reported lower URTI and TI status in the vitamin D sufficient versus insufficient children. Also, URTI and TI status were found to be significantly (P < 0.0001) lower in children with improved 25(OH)D versus unchanged 25(OH)D.
CONCLUSIONS
Vitamin D-calcium supplementation helped to improve the vitamin D status but exerts no effect on the occurrence of infections when compared to the placebo group. Improvement in the serum 25(OH)D concentrations and attainment of vitamin D sufficiency may exert a beneficial effect on the infection status and needs to be investigated further. To evaluate the efficacy of zinc supplementation, higher dosages need to be administered in future studies.

Keyword

zinc sulfate; respiratory tract infections; India; calcium carbonate; Cholecalciferol

MeSH Terms

Arm
Calcium
Calcium Carbonate
Child
Cholecalciferol
Colorimetry
Enzyme-Linked Immunosorbent Assay
Humans
India
Respiratory Tract Infections
Risk Factors
Vitamin D
Vitamins*
Zinc Sulfate
Zinc*
Calcium
Calcium Carbonate
Cholecalciferol
Vitamin D
Vitamins
Zinc
Zinc Sulfate

Figure

• 

  Fig. 1 CONSORT Diagram for participant flow

• 

  Fig. 2 Change in serum 25(OH)D status from baseline to endline. *Significantly different from baseline vitamin D-calcium (P < 0.001), #Significantly different from baseline Zinc (P < 0.05), §Significantly different from baseline Placebo (P < 0.001), †Significantly different from endline vitamin D-calcium (P < 0.0001)

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