Determinants and Effects of Vitamin D Supplementation in Postmenopausal Women: A Systematic Review
Abstract
:1. Introduction
2. Methods
2.1. Study Protocol and Guidance
2.2. Databases Searched and Search Strategy
2.3. Study Selection
2.4. Inclusion/Exclusion of Studies
2.5. Strategy for Data Extraction and Synthesis
2.6. Risk of Bias (RoB) Assessment
3. Results
3.1. Search Results
3.2. Study Characteristics
3.3. Risk of Bias
4. Discussion
4.1. The Effect of Treatment Duration and Dose on Vitamin D Status
4.2. The Effects of Type of Vitamin D on Vitamin D Status
4.3. The Effects of Baseline Serum 25(OH)D on Vitamin D Status
4.4. The Effect of Sun Exposure on Vitamin D Status
4.5. The Effect of Lifestyle Habits and Dietary Intake on Vitamin D Status
4.6. Effect of Ethnicity and Genetics
5. Limitations
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Data Availability Statement
Conflicts of Interest
References
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Intervention and Comparators (Dose, Frequency, and Length of Intervention) | Outcome | Baseline Mean (SD) | Outcome Mean (SD) | p Value | Outcome Measure | Findings |
---|---|---|---|---|---|---|
(Pérez-Castrillón et al., 2021) [44] Spain and Italy | ||||||
Calcifediol 0.226 mg/month for four months, then eight months placebo | 25(OH)D3 (ng/mL) | 12.8 (3.9) | 29.7 (8.6) | <0.0001 | Chemiluminescence immunoassay, the intra-assay coefficient of variation (CV) was 2.34, and the inter-assay coefficient of variation was 5.06% | Calcifediol is more effective than cholecalciferol in increasing serum 25(OH)D levels. |
Cholecalciferol 25,000 IU/month for 52 weeks | 13.2 (3.7) | 23.8 (5.0) | ||||
Calcifediol 0.226 mg/month for four months, then eight months placebo | Free 25(OH)D (pg/mL) | 3.8 (1.1) | 7.6 (2.5) | |||
Cholecalciferol 25,000 IU/month for 52 weeks | 4.0 (1.1) | 6.5 (1.6) | ||||
(Mueangpaisarn and Chaiamnuay, 2020) [43] Thailand | ||||||
Vitamin D 40,000 IU/week for 12 weeks | 25(OH)D3 (ng/mL) | 19.4 (6.2) | 34.5 (9.1) | <0.001 | Electroluminescence immunoassay, the intra-assay coefficient of variability was 3.65, and the inter-assay coefficient of variability was 4.10 | Higher doses were more effective at raising serum 25(OH)D compared to the low dose |
Vitamin D 100,000 IU/week for 12 weeks | 19.1 (6.5) | 51.7 (19.3) | ||||
(Watcharanon et al., 2018) [49] Thailand | ||||||
Vitamin D2 20,000 IU/week for 12 weeks | 25(OH)D3 (ng/mL) | 29.98 (6.35) | 32.44 (7.33) | <0.01 | Electroluminescence immunoassay with a coefficient variation of 3.7–4.5% | A combination of both vitamin D and sun exposure is more effective in raising serum 25(OH)D levels than sun exposure only in postmenopausal women |
Sunlight exposure for 12 weeks | 32.30 (6.97) | 29.68 (6.28) | ||||
(Reyes-Garcia et al., 2018) [46] Spain | ||||||
Semi-skimmed milk calcium 180 mg/100 mL and vitamin D 120 IU/100 mL + Fructooligosaccharides (FOS) 5 g/L | 25(OH)D3 (ng/mL) | 21.4 (6.7) | 26.6 (6.4) | <0.001 | Chemiluminescence immunoassay | Daily intake of calcium and vitamin D-fortified milk significantly improves vitamin D status in postmenopausal Thai women |
Semi-skimmed milk calcium 180 mg/100 mL and vitamin D 120 IU/100 mL + Fructooligosaccharides (FOS) 5 g/L | 22.3 (9.4) | 25.2 (6.2) | ||||
Calcium 120 mg/100 mL and vitamin D 30 IU/100 mL | 21.8 (7.1) | 22.6 (7) | ||||
(Kruger et al., 2018) [37] Malaysia | ||||||
Vitamin D 15 ug/day + calcium 1200 mg | 25(OH)D3 (nmol/L) | 62.3 (1.89) | 74.8 (2.74) | <0.001 | Liquid chromatography–mass spectrometry | Daily intake of calcium and vitamin D-fortified milk significantly improves vitamin D status in postmenopausal Chinese women |
Regular milk powder, 428 mg calcium | 64.8 (18.89) | 63.1 (2.87) | ||||
(Bonjour et al., 2018) [35] Brazil | ||||||
Vitamin D3-fortified yogurt 5 ug/day for 16 weeks, followed by eight weeks without product | 25(OH)D3 (nmol/L) | 36.5 (14.6) | 52.6 (17) | 0.008 | Enzyme-linked immunosorbent assay (ELISA) and electroluminescence immunoassay. The intra-assay and inter-assay variations were less than 7% for both. | A dose-dependent improvement in serum 25(OH)D with fortified yogurt and an inversely baseline-dependent increase in serum 25(OH)D |
Vitamin D3-fortified yogurt 10 ug/day for 16 weeks, followed by eight weeks without product | 35.9 (14.8) | 58.9 (19.9) | 0.0008 | |||
Regular dietary habits | 36.4 (15.8) | 49.5 (18.8) | ||||
(Apaydin et al., 2018) [33] Turkey | ||||||
Vitamin D3 800 IU/day for 12 weeks | 25(OH)D3 (nmol/L) | 24.2 (10.9) | 57.6 (11.7) | <0.001 | Chemiluminescence immunoassay | A single high oral dose of vitamin D is more effective than a daily low dose in raising serum 25(OH)D |
Oral vitamin D3 single dose 300,000 IU | 25.4 (10.9) | 49.4 (17.9) | ||||
(Venugopal et al., 2017) [48] Malaysia | ||||||
Oral cholecalciferol 50,000 IU/monthly for 12 weeks | 25(OH)D3 (nmol/L) | 90.2 (23.1) | 96 (24.1) | 0.057 | Electro-chemiluminescence immunoassay (ECLIA). Intra-assay coefficient of variation, mean of 38.8 nmol/L −12.2% and mean of 169.5 nmol/L −2.2% | Both doses can safely maintain vitamin D sufficiency. Higher doses were required with baseline serum levels of <75 nmol/L |
Oral cholecalciferol 25,000 IU/monthly for 12 weeks | 91.2 (24.6) | 107.1 (22.7) | ||||
(Minisola et al., 2017) [42] Italy | ||||||
Oral calcidiol 20 ug/day for 12 weeks | 25(OH)D3 (nmol/L) | 15.1 (7.4) | 49.3 (19.5) | <0.0001 | Liquid chromatography–mass-spectrometry. Intra-assay coefficient variation <5% and intra-assay <6% | Calcidiol in all dosage schemes significantly increased serum 25(OH)D in postmenopausal women and can be considered an alternative to cholecalciferol |
Oral calcidiol 40 ug/day for 12 weeks | 16.8 (6.6) | 74.8 (22.5) | ||||
Oral calcidiol 125 ug/week for 12 weeks | 16.4 (9.7) | 46.4 (15) | ||||
(Manios et al., 2017) [40] Greece | ||||||
Vitamin D3-enriched Gouda-type cheese 5.7 ug/day for eight weeks | 25(OH)D3 (nmol/L) | 47.3 (15.2) | 52.5 (12) | <0.001 | Chemiluminescence immunoassay. Intra-assay 8.9% and inter-assay 12.8% | Supplementation was sufficient in raising serum 23(OH)D levels throughout the winter season |
Non-enriched reduced-fat cheese for eight weeks | 42.9 (17.7) | 38.3 (18.9) | ||||
(Zhang et al., 2017) [50] China | ||||||
Cholecalciferol 1100 IU/day + calcium 1500 mg/day for 52 weeks | 25(OH)D3 (nmol/L) reported as changes in mean 25(OH)D | 74.1 (18.5) | 24.31 (17.02) | <0.0001 | Radioimmunoassay | Polymorphisms in CYP2R1 and GC genes may be associated with differences in response to supplements in postmenopausal Caucasian women. |
Calcium 1500 mg/day for 52 weeks | 73.4 (21.6) | −1.02 (11.12) | ||||
Cholecalciferol 2000 IU/day + calcium 1500 mg/day for 52 weeks | 80.1 (25.5) | 31.92 (43.96) | ||||
Control placebo | 80.8 (31.7) | 0.36 (41.17) | ||||
(Gallagher et al., 2012) [36] USA | ||||||
Vitamin D3 for 52 weeks | ||||||
400 IU/day | 25(OH)D3 (nmol/L) | 37.8 (10.8) | Serum concentrations were reported as a dose-response mixed-effect model | <0.001 | Radioimmunoassay, the inter-assay variation was 10.3% for 32.5 ng/mL and 12.7% for 70 ng/mL | Low doses of vitamin D3 of 600 IU and 800 IU/day were effective in raising serum 25(OH)D levels to greater than 50 nmol/L in postmenopausal women |
800 IU/day | 39.0 (9.5) | |||||
1600 IU/day | 37.4 (10.2) | |||||
2400 IU/day | 38.2 (10.1) | |||||
3200 IU/day | 39.8 (8.2) | |||||
4000 IU/day | 37.2 (9.2) | |||||
4800 IU/day | 38.6 (9.1) | |||||
(Bischoff-Ferrari et al., 2012) [34] Switzerland | ||||||
Vitamin D3 800 IU/day For 16 weeks | 25(OH)D3 (nmol/L) | 14.18 (3.61) | 30.99 (1.59) | <0.0001 | Liquid chromatography coupled to tandem mass spectrometry detection (HPLC-MS/MS) | Oral supplementation with (25(OH)D3 metabolite) at doses of 20 ug/day is safe and resulted in a rapid and prolonged increase in 25(OH)D levels compared with vitamin D3 |
25(OH)D3 (HyD) 800 IU/day for16 weeks | 12.28 (4.08) | 69.47 (1.58) | ||||
Vitamin D3 5600 IU/week for 16 weeks | 1,25(OH)2D (pmol/L) | 38.61 (12.10) | 40.50 (2.91) | 0.004 | ||
25(OH)D3 (HyD) 5600 IU/week for16 weeks | 33.02 (13.63) | 53.06 (2.76) | ||||
(Kruger et al., 2012) China | ||||||
Calcium 900 mg and vitamin D-fortified milk 6.4 ug/day for 12 weeks | 25(OH)D3 (nmol/L) | 33.13 (15.5) | (33.13–39.49) | <0.001 | Electroluminescence immunoassay. Intra-assay coefficient variation is 5.1%, and inter-assay is 4.8% | High-calcium vitamin D-fortified milk was effective and significantly improved vitamin D status in postmenopausal Chinese women |
Powdered control rice-based drink | 29.27 (12.03) | (29.27–28.21) | ||||
(Kruger et al., 2010) [39] | ||||||
High-calcium vitamin D-fortified milk—9.6 ug/day for 16 weeks (Indonesia) | 25(OH)D3 (nmol/L) | 45.06 (2.01) | - | <0.001 | Electroluminescence immunoassay | High-calcium vitamin D-fortified milk was effective and significantly improved vitamin D status in two groups of Southeast Asian postmenopausal women |
Powdered control rice-based drink | 43.33 (2.01 | - | ||||
High-calcium vitamin D-fortified milk—9.6 ug/day for 16 weeks (Philippines) | 62.0 (2.87) | - | ||||
Powdered control rice-based drink | 59.23 (2.87) | - | ||||
(Pignotti et al., 2010) [45] Brazil | ||||||
Vitamin D3 400 IU/day + 600 mg calcium for 12 weeks | 25(OH)D3 (nmol/L) | 46.67 (13.97) | 59.47 (17.5) | 0.023 | Radioimmunoassay. Inter-assay coefficient variation 12% | Supplementation with 400 IU/day was not enough to raise serum concentrations of 25(OH)D to levels considered optimal for bone turnover in postmenopausal osteoporotic women |
General orientation on a healthy diet | 52.87 (21.40) | 58.8 (24.72) | - | |||
(Talwar et al., 2007) [47] USA | ||||||
Vitamin D3 800 IU/day for 24 months | 25(OH)D (nmol/L) | 46.9 (20.6) | 65.9 (22.4) | <0.0001 | Radioimmunoassay. Inter-assay coefficient variation 7% | Supplementation with 2000 IU/day oral vitamin D3 was sufficient to raise serum 25(OH)D concentrations to >50 nmol/L in Black African American postmenopausal women |
Control | 43.2 (16.8) | 41.6 (18.1) | - | |||
Vitamin D3 800 IU/day for 24 months | 1,25(OH)2D (pmol/L) | 121.3 (39.2) | 107.6 (33.6) | - | ||
Control | 119.2 (39.2) | 87.4 (33.6) | - | |||
(Mastaglia et al., 2006) [41] Argentina | ||||||
Oral drops of vitamin D2—5000 IU/Day for 12 weeks | 25(OH)D (nmol/L) | 42.0 (23.7–45.0) | 7.5 (66.2–156.2) | <0.001 | Radioimmunoassay. Intra-assay coefficient variation 7.6%, and inter-assay 19% | Vitamin D2 was effective at raising serum 25(OH)D levels to 85 nmol/L in postmenopausal osteoporotic women |
Oral drops of vitamin D2—10,000 IU/Day for 12 weeks | 32.5 (27.5–37.5) | 97.7 (79.3–123.1) | ||||
Control (placebo) | 45.0 (31.2–61.2) | 55.0 (72.5–68) | <0.01 | |||
(Aloia et al., 2005) [32] USA | ||||||
Vitamin D3 800 IU/day + calcium 1500 mg/day for 24 months, then 2000 IU for another 12 months | 25(OH)D (ng/mL) | 19.3 (8.36) | 34.8 | <0.001 | Radioimmunoassay | Supplementation with 20 ug/day oral vitamin D3 was sufficient to raise serum 25(OH)D concentrations to a mean of 89.9 nmol/L in Black African American postmenopausal women |
Control (placebo) | 17.2 (6.64) | - | - | |||
Vitamin D3 800 IU/day + calcium 1500 mg/day for 24 months, then 2000 IU for another 12 months | 1,25(OH)2D (pmol/L) | 46.5 (15.2) | - | - | ||
Control (placebo) | 45.7 (15.10) | - | - |
Trial | Population | Sample Size | Drop out (n) | Adverse Events | Compliance Rate | Compliance Assessment |
---|---|---|---|---|---|---|
(Bonjour et al., 2018 [35] | Healthy postmenopausal women | 140 | 7 | - | 93−100% | Completed a questionnaire regarding adherence and acceptability in a dairy. Adherence was measured by returning yogurt lids |
(Reyes-Garcia et al., 2018) [46] | Healthy postmenopausal women | 461 | 94 | Adverse events not reported | 80% | By a food frequency questionnaire at baseline, 12 months, and end of the study |
(Kruger et al., 2018) [37] | Healthy Chinese Malaysian postmenopausal women | 121 | 23 | Adverse events not reported | 86–90% | Phone calls were made to monitor milk consumption, and each subject was provided with a monthly diary to record their intake daily |
(Manios et al., 2017) [40] | Healthy postmenopausal women | 80 | 1 | - | 97.50% | Bi-weekly meetings and telephone communication. Participants were provided with a diary to record their intake daily |
(Kruger et al., 2012) [38] | Healthy Chinese postmenopausal women | 63 | 5 | Two events; one of constipation and stomach discomfort and one of cancer (unrelated to the intervention) | 98% | Phone calls were made to monitor milk consumption, and each subject was provided with a monthly diary to record their intake daily |
Kruger et al., 2010 [39] | Healthy Asian postmenopausal women | 120 | 3 | Two events of lactose intolerance and one of gastrointestinal discomfort | 98–99.6% | Participants were provided with a diary to record their intake daily |
(Pérez-Castrillón et al., 2021) [44] | White postmenopausal women with (32) and without osteoporosis (266) | 303 | 5 | Nine adverse events were reported (not specified) | - | Dietary calcium consumption at baseline, 4, 8, and 12 months was assessed using an adapted version of a validated questionnaire |
(Mueangpaisarn and Chaiamnuay, 2020) [43] | Asian postmenopausal women with vitamin D deficiency | 94 | 9 | Three adverse events: constipation; chest pain, and one hip fracture | >80% | Did not report |
(Watcharanon et al., 2018) [49] | Healthy Asian postmenopausal women | 52 | - | None | - | Did not report |
(Apaydin et al., 2018) [33] | Healthy postmenopausal women | 60 | - | - | - | Did not report |
(Venugopal et al., 2017) [48] | Chinese Malaysian postmenopausal osteoporotic women | 90 | - | - | - | The study intervention was administered monthly at the clinic under the direct supervision of the investigator |
(Minisola et al., 2017) [42] | Postmenopausal women with vitamin D deficiency | 87 | Four events: three reported flu and one hypercalcemia possibly related to the intervention | - | Compliance was recorded at each of the study time points (not specified how) | |
(Zhang et al., 2017) [50] | Non-Hispanic White postmenopausal women | 2207 | - | - | - | By bottle weight. Empty and full bottles were weighed, and then the resulting subtraction was divided by the number of tablets in the bottle |
(Gallagher et al., 2012) [36] | Healthy postmenopausal White women with vitamin D insufficiency | 163 | 16 | Three events: one hypercalciuria, one myocardial infarction, and one congestive heart failure | 86–90% | By counting pills |
(Bischoff-Ferrari et al., 2012) [34] | Healthy White postmenopausal women | 20 | - | By capsule count at each study visit and by measuring the serum concentration of 25(OH)D at the end of the study | ||
(Pignotti et al., 2010) [45] | Caucasian postmenopausal osteoporotic women | 64 | 6 | - | - | Dietary intake was collected through 3-day food record and checked and calculated by nutrition software (Nutrition Data System for Research, University of Minnesota) |
(Talwar et al., 2007) [47] | Healthy Black African-American postmenopausal women | 208 | - | Eight severe hypercalcemia events, none of which was considered to be related to the study intervention | 87% | Food frequency questionnaire at each visit to assess calcium intake |
(Mastaglia et al., 2006) [41] | Postmenopausal osteoporotic women | 45 | 45/7 | Three cases of hypercalciuria | 89–92% | By pill counts and drop counts in each box and vial returned at each monthly visit |
(Aloia et al., 2005) [32] | Healthy Black African-American postmenopausal women | 208 | 19 | 222 adverse events were reported over the study period of three years | - | Food frequency questionnaire at each visit to assess calcium intake |
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Hassanein, M.M.; Huri, H.Z.; Baig, K.; Abduelkarem, A.R. Determinants and Effects of Vitamin D Supplementation in Postmenopausal Women: A Systematic Review. Nutrients 2023, 15, 685. https://doi.org/10.3390/nu15030685
Hassanein MM, Huri HZ, Baig K, Abduelkarem AR. Determinants and Effects of Vitamin D Supplementation in Postmenopausal Women: A Systematic Review. Nutrients. 2023; 15(3):685. https://doi.org/10.3390/nu15030685
Chicago/Turabian StyleHassanein, Mohammed M., Hasniza Zaman Huri, Kauser Baig, and Abduelmula R. Abduelkarem. 2023. "Determinants and Effects of Vitamin D Supplementation in Postmenopausal Women: A Systematic Review" Nutrients 15, no. 3: 685. https://doi.org/10.3390/nu15030685