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Table 4 Characteristics and main findings of studies looking at different doses of vitamin D supplementation [17, 18]

From: Vitamin D prophylaxis in infancy

Ref Setting, date of publication Participants Interventions: regimens of vitamin D Findings
[21] China 1992 312 healthy term infants (A) 100 IU/day
(B) 200 IU/day
(C) 400 IU/day
Initiated at 3 to 5 days of life, up to 6 months of age.
Adequate levels of 25OHD above the rachitic range (equivalent to severe deficiency of less than 11 ng/mL) were more frequently achieved among infants receiving the 400 IU dosages compared to the 100 and 200 IU dosages.
[20] Afghanistan 1994 Infants with vitamin D deficiency (25OHD < 25 nmol/L) (A) Single dose of 600,000 IU at birth
(B) Single dose of 200,000 IU at birth
(C) 100,000 IU at birth, 3 and 6 months
(C) provided the best protection against vitamin D deficiency without reaching unacceptably high concentrations of 25OHD.
[24] Louisiana 2010 80 breastfed babies (A) 200 IU from day 1 to 6 months
(B) 200 IU from month 2 to 6 months
(C) placebo
No differences in 25OHD, Calcium, or Phosphorous concentrations between (A) and (B) at 2, 4, and 6 months of age.
At 4 months of age, the 25OHD serum concentration of (C) was significantly lower than (A) and (B).
No cases of rickets in any of the 3 groups.
Author conclusion “universal supplementation is not necessary for rickets prevention in Southern Louisiana”
[26] Iran 2010 129 infants (A) 200 IU/day
(B) 400 IU/day
(C) 50,000 IU/month
Serum 25OHD concentration at 6 months of age:
(A) 20 to 51 ng/ml
(B) 23 to 64 ng/ml
(C) 28 to 102 ng/ml
[27] Spain 2011 88 term infants, not all exclusively breastfed (A) 400 IU/day for 12 months
(B) No vitamin D supplements
Serum 25OHD concentration:
• At 3 months of age: (A) 41.8 +/−  16.7 ng/ml; (B) 27.6 +/−  12.8 ng/ml; p < 0.001
• At 6 months of age: (A) 43.8 +/−  13.8 ng/ml; (B) 32.5 +/−  8.9 ng/ml; p < 0.001
• At 12 months of age: no differences between (A) and (B)
Parathyroid hormone: no differences between (A) and (B) at any time.
No clinical rickets in neither group.
[28] Germany 2011 40 term infants (A) 250 IU/day
(B) 500 IU/day
Starting in summer or in winter, follow-up of 6 weeks.
Serum 25OHD concentrations at six weeks:
(A) 45.6 ng/ml to 65.6 ng/ml
(B) 50 ng/ml to 70 ng/ml
No seasonal variations in 25OHD concentrations.
[29] Finland 2012 113 breastfed infants recruited at 2 weeks of age (A) 400 IU/day
(B) 1200 IU/day
(C) 1600 IU/day
Follow-up of 12 weeks.
Only (C) maintained serum 25OHD concentration > 32.5 ng/mL in all infants without hypercalcemia or hypercalciuria. In (B) and (C) some infants reached 25OHD concentrations > 80 ng/mL.
Bone density (peripheral quantitative computed tomography): no significant differences between the 3 groups.
[30] Turkey 2013 169 breastfed term babies (A) 200 IU/day
(B) 400 IU/day
Serum 25OHD concentrations at 4 months:
(A) median of 39.6 ng/ml (range 17.05 to 106)
(B) median of 56.5 ng/ml (range 32 to 150.2); with significant differences (p < 0.001)
Proportion of infants with serum 25OHD < 30 mg/ml at 4 months:
(A) 21.3%
(B) 0%
No clinical rickets in either group.
[31] Canada 2013 51 term infants (A) Vit D2 400 IU/day
(B) Vit D3 400 IU/day
No differences in increase of plasma 25OHD from baseline between (A) and (B) after 3 months
[23] Canada 2013 132 breastfed infants recruited at 1 month of age (A) 400 IU/day
(B) 800 IU/day
(C) 1200 IU/day
(D) 1600 IU/day
Follow-up for 11 months, reassessed at 1 year of age.
Plasma 25OHD levels of ≥50 nmol/L (20 ng/ml) in 97% (95% CI 94 to 100) of infants at 3 months, and sustained in 98% (95% CI 94 to 100) of infants at 12 months in all groups.
Plasma 25OHD concentration ≥ 75 nmol/L (30 ng/ml) in 97.5% of infants at 3 months only in (D).
The (D) dose led to 25OHD concentration (> 150 ng/ml) that may cause hypercalcemia (potential toxicity).
No differences in growth and bone mineral content between groups.
Authors concluded that “dosages of vitamin D higher than 400 IU per day provide no additional benefits for bone mineral accretion.”
[32] Canada 2016 Follow-up of [23] at 3 years of age Same as above Bone health at 3 years of age:
“Lumbar spine vertebrae 1–4 bone mineral density, lumbar spine and whole body bone mineral content, and mineral accretion, measured by dual-energy X-ray absorptiometry were similar among all treatment groups.”
[33] Canada 2017 Follow-up of [23] at 3 years of age Same as above Body composition (by anthropometric measurements and from the dual-energy X-ray absorptiometry measurements): no differences between the 3 groups.
“However when all infants were combined, there was a weak correlation between 25OHD measurements and lean body mass, although this correlation may have only reflected subtle differences in outdoors physical activity rather than differences because of treatment group allocation.”
[25] Afghanistan 2013 3046 children between 1 and 11 months of age Vitamin D:
(A) 100,000 IU/3 months; 6 doses
(B) Placebo/3 months; 6 doses
Occurrence of diarrheic episodes during the 18-months follow-up period: no significant differences between (A) and (B).
Serum 25OHD concentrations: not assessed.