TABLE 2.
Characteristics of included mass balance studies reporting calcium outcomes in infants and children aged 0–4 y1
| Author, year; country | Calcium outcomes | Age, mean ± SD, y (range, d) | Racial/ethnic background | Health status | Total enrolled n; % male | Run-in diet | Habitual diet assessment | Study arm: calcium content | Duration of food consumption, d | Duration of urine collections, h | Duration of fecal collections, h | Calcium assessment methods |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barnes et al., 1974 (22); USA | Intake, absorption, retention | 0 ± 0 (NR) | NR | 100% healthy | 29; 100 | Yes | Yes | Formula J (Ca/P 1.7): 0.53 mg/gFormula K (Ca/P 1.4): 0.70 mg/gFormula L (Ca/P 1.3): 0.65 mg/g | 6 | 144 | 144 | EDTA procedure |
| Barltrop et al., 1977 (13); United Kingdom | Intake, urinary excretion, fecal excretion, absorption, retention | 0 ± 0 (4–41) | NR | 100% healthy | 13; 92.3 | Yes | Yes | Formula L (Ca/P 0.6); P supp.: NRFormula M (Ca/P 1.2); No supp.: NRFormula H (Ca/P 2.4); Ca supp.: NR | 4–41 | 48 | 48 | AAS |
| Carnielli et al., 1996 (23); Netherlands | Intake, urinary excretion, fecal excretion, absorption, retention | 0 ± 0 (NR) | NR | 100% healthy | 27; 100 | Yes | NR | Beta (β) formula: 52.5 mg/100 mLIntermediate formula: 53 mg/100 mLRegular formula: 54 mg/100 mL | 28 | 24 | 72 | AAS |
| Clemente Yago et al., 19892 (20); Spain | Intake, urinary excretion, fecal excretion, absorption, retention | 0.1 ± 0.1 (3–160) | NR | 100% healthy | 20; NR | NR | NR | Milk formula (Ca/P 1.6): 0.6 mg/mL (106.5 mg/[kg*d]) | 3 | 72 | 72 | AAS |
| DeVizia et al., 1985 (15); USA | Intake, urinary excretion, fecal excretion, absorption, retention | 0 ± 0 (22–237) | 100% non-Hispanic white | 100% healthy | 6; 83.3 | Yes | NR | Formula LCa (Ca/P 0.8): 0.39 mg/mLFormula MCa (Ca/P 1.4): 0.66 mg/mLFormula HCa (Ca/P 2.0): 1.02 mg/mL | 3 | 72 | 72 | AAS |
| Fomon et al., 1963 (19); USA | Intake, urinary excretion, fecal excretion, retention | 0 ± 0 (8–182) | NR | 100% healthy | 283; 64.3 | Yes | NR | Human milk: 32.9 mg/100 mLFormula 22-3C: 41.9 mg/100 mLFormula 22-3D: 36.3 mg/100 mLFormula 22-3E: 45.8 mg/100 mLFormula S-26: 42.6 mg/100 mLSimilac: 73.8 mg/100 mL | 30–1804 | 72 | 72 | (1912) McCrudden's method |
| Hanna et al., 1970 (24); USA | Intake, urinary excretion, fecal excretion, absorption, retention | 0 ± 0 (NR) | NR | 100% healthy | 38; 81.6 | Yes | NR | Transitional breast milk (Ca/P 1.4): 0.26 mg/gLyophilized mature human milk reconstitute (Ca/P 1.5): 0.21 mg/gFormula A (Ca/P 1.1): 0.47 mg/gFormula B (Ca/P 1.4): 0.42 mg/g | 6 | 144 | 144 | AAS |
| Manz et al., 19895 (14); Germany | Intake, urinary excretion, fecal excretion, absorption, retention | 0 ± 0 (13–54) | NR | Preterm infants | 19; NR | NR | NR | Standard formula (Ca/P 1.4): 0.54 mg/mLCa-L-lactate supp formula (Ca/P 2.0): 0.80 mg/mL | Mean (range) SF: 29 (13–54)CF: 15 (13–23) | 8–12 (2x) | 8–12 (2x) | AAS |
| Moya et al., 19825 (21); Spain | Intake, excretion (urine + fecal), absorption, retention | 0 ± 0 (1–3) | NR | Low BW infants | 26; NR | NR | NR | Formula A (Ca/P 2.4): 0.83 mg/mLFormula B (Ca/P 1.7): 0.73 mg/mLFormula C (Ca/P 4.2): 1.70 mg/mL | 3 | 72 | 72 | AAS |
| Moya et al., 1998 (26); Spain | Intake, fecal excretion, absorption, retention | 0 ± 0 (2–8) | NR | 100% healthy | 19; NR | Yes | NR | Standard formula (Ca/P 1.5): 0.59 mg/gLactose-free formula (Ca/P 1.6): 0.65 mg/g | 3 | 72 | 72 | AAS |
| Nelson et al., 1998 (25); USA | Intake, fecal excretion, absorption | 0 ± 0 |(22–192) | NR | 100% healthy | 10; 60 | Yes | NR | Palm olein formula: 580 mg/LHigh oleic safflower oil formula: 569 mg/L | 3 | — | 72–96 | AAS |
| Ostrom et al., 2002 (18); USA | Intake, fecal excretion, absorption | 0 ± 0 (75–89)6 | NR | 100% healthy | 357; 48.6 | Yes | NR | Casein hydrolysate + iron formula: 724 mg/LCasein hydrolysate + iron formula: 856 mg/LSoy protein + iron formula: 752 mg/LSoy protein + iron formula: 739 mg/L | 3 | — | 72 | AAS |
| Oliveira de Souza et al., 2017 (16); Brazil | Intake, urinary excretion, fecal excretion, absorption, retention | 0.2 ± 0 (68–159) | NR8 | 100% healthy | 33 (17)9; 53.1 | Yes | NR | Formula PALM: 279 mg/100 gFormula NoPALM: 424 mg/100 g | 14 | 72 | 72 | AAS |
| Zannino et al., 1983 (27); Italy | Intake, fecal excretion, absorption | 0 ± 0 (4) | NR | 100% healthy | 36; 100 | NR | NR | Eulac formula: 43 mg/100 gHuman milk: 33 mg/100 mL | 4 | — | 7210 | GEMENI self-analyzer |
| Ziegler et al., 198311 (17); USA | Intake, urinary excretion, fecal excretion, absorption, retention | 0 ± 0 (27–382) | NR | 100% healthy | 6; 83.3 | Yes | NR | Lactose formula: 669 mg/LPolycose and sucrose formula: 603 mg/L | 11 | 72 | 72 | AAS |
AAS, atomic absorption spectrophotometry; BW, birth weight; Ca, calcium; CF, Ca-L-lactate supp formula; EDTA, Ethylenediaminetetraacetic acid; HCa, high calcium formula;LCa, low calcium formula; MCa, moderate calcium formula; NoPALM, formula without olein palm or palm kernel oil; NR, not reported; P, phosphorus; PALM, formula with olein palm or palm kernel oil; SF, standard formula; supp, supplement.
Some or all participants were given vitamin D supplementation.
Study indicated only 25 participants had assessments of metabolic balance. However, 28 infants provided individual data on calcium and phosphorus balance, as shown in Table 3.
Duration of formula and/or human milk consumption ranged from the first 4 wk to 6 mo of life.
Health status was within systematic review acceptable parameters.
Mean age at study entry ranged from 75 to 89 d. Thus, it can be assumed metabolic balance studies were conducted with infants who were aged between 91 and 181 d.
35 infants were enrolled in the study, however, only 22 infants provided data in the postmetabolic balance period.
In the same clinical trial conducted by Leite et al. (28), 33 subjects were enrolled, of which 61% were referred to as “mulatto,” 36% were black, and 3% were described as “brown,” by the authors.
33 subjects were enrolled in the study. Of these, 17 subjects were included in the metabolic balance phase.
250 mg of carmine red in 5% glucose solution was administered. Stool collection began when the first marked stools appeared. After 36 h a second administration of carmine red was made. When the feces marked by the 2nd administration of carmine red appeared, the collection stopped, with the exclusion of this last sample.
Mean age at study entry ranged from 27 to 382 d. Mean age at study completion ranged from 105 to 457 d.