Efficacy of Weekly Split versus Single Doses of Ergocalciferol on Serum 25-Hydroxyvitamin D among Patients on Continuous Ambulatory Peritoneal Dialysis: A Randomized Controlled Trial

Background. Vitamin D deficiency is a common problem among patients on continuous ambulatory peritoneal dialysis (CAPD). Vitamin D supplementation leads to reduced serum parathyroid hormone levels and improved cardiovascular markers. Different doses and time intervals of oral vitamin D supplementation may differ in each patient on dialysis. The study aimed to evaluate the efficacy of weekly split and single dose of ergocalciferol at 60,000 IU on serum 25-hydroxyvitamin D (25(OH)D) among patients on CAPD. Methods. A randomized study was conducted among patients on CAPD with vitamin D deficiency or insufficiency (25(OH)D < 30 ng/mL). Patients were randomly assigned to two groups: the split dose group was given ergocalciferol 20,000 IU three times weekly and the single dose group was given ergocalciferol 60,000 IU once weekly for 8 weeks. Main outcomes measured serum 25(OH)D concentrations, serum calcium, serum phosphate, and intact parathyroid levels at 8 weeks after being enrolled. Results. Of 128 screened patients, 50 met the criteria for eligibility and were randomized. At 8 weeks after treatment, mean serum 25(OH)D concentrations significantly increased from baseline 22.7 ± 5.9 to 29.5 ± 9.5 ng/mL P = 0.004 in the split dose group and 22.9 ± 5.3 to 31.2 ± 12.3 ng/mL P = 0.003 in the single dose group. No significant change was found in increase of serum 25(OH)D between the two groups P = 0.561 . At the end of study, a similar proportion of patients in both groups reached the desirable serum concentration of 25(OH)D ≥ 30 ng/mL (60% in the single group vs. 40% in the split group, P = 0.258 ). No significant cases of hypercalcemia, hyperphosphatemia, or serious adverse events occurred during the study. Conclusion. Weekly single and split doses of ergocalciferol 60,000 IU achieved similar effects on serum 25(OH)D levels among patients on CAPD with vitamin D insufficiency or deficiency, suggesting that weekly single dose would be prescribed for adequate vitamin D repletion. This trial is registered with TCTR20200821005.

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Serum 25-Hydroxyvitamin D Level Could Predict the Risk for Peritoneal Dialysis-Associated Peritonitis

Peritoneal Dialysis International ◽

10.3747/pdi.2014.00177 ◽

2015 ◽

Vol 35 (7) ◽

pp. 729-735 ◽

Cited By ~ 4

Author(s):

Hai-Chen Pi ◽

Ye-Ping Ren ◽

Qin Wang ◽

Rong Xu ◽

Jie Dong

Keyword(s):

Vitamin D ◽

Peritoneal Dialysis ◽

Vitamin D Deficiency ◽

Vitamin D Supplementation ◽

Active Vitamin ◽

Baseline Serum ◽

Hydroxyvitamin D ◽

Active Vitamin D ◽

25 Hydroxyvitamin D ◽

The Mean

BackgroundAs an immune system regulator, vitamin D is commonly deficient among patients on peritoneal dialysis (PD), which may contribute to their impaired immune function and increased risk for PD-related peritonitis. In this study, we aimed to investigate whether vitamin D deficiency could predict the risk of peritonitis in a prospective cohort of patients on PD.MethodsWe collected 346 prevalent and incident PD patients from 2 hospitals. Baseline demographic data and clinical characteristics were recorded. Serum 25-hydroxyvitamin D (25[OH]D) was measured at baseline and prior to peritonitis. The mean doses of oral active vitamin D used during the study period were also recorded. The outcome was the occurrence of peritonitis.ResultsThe mean age of patients and duration of PD were 58.95 ± 13.67 years and 28.45 (15.04 – 53.37) months, respectively. Baseline 25(OH)D level was 16.15 (12.13 – 21.16) nmol/L, which was closely associated with diabetic status, longer PD duration, malnutrition, and inflammation. Baseline serum 25(OH)D predicted the occurrence of peritonitis independently of active vitamin D supplementation with a hazard ratio (HR) of 0.94 (95% confidence interval [CI] 0.90 – 0.98) after adjusting for recognized confounders (age, gender, dialysis duration, diabetes, albumin, residual renal function, and history of peritonitis). Compared to the low tertile, middle and high 25(OH)D level tertiles were associated with a decreased risk for peritonitis with HRs of 0.54 (95% CI 0.31 – 0.94) and 0.39 (95% CI 0.20 – 0.75), respectively.ConclusionsVitamin D deficiency evaluated by serum 25(OH)D rather than active vitamin D supplementation is closely associated with a higher risk of peritonitis.

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VITAMIN D SUPPLEMENTATION IN FEMALE NURSES: THE EFFECTS ON SERUM 25-HYDROXYVITAMIN D, AND NON-SPECIFIC MUSCULOSKELETAL PAIN

Journal of Musculoskeletal Research ◽

10.1142/s0218957715500086 ◽

2015 ◽

Vol 18 (02) ◽

pp. 1550008 ◽

Cited By ~ 2

Author(s):

Negin Masoudi Alavi ◽

Mahla Madani ◽

Mohsen Taghizadeh ◽

Mohammad Reza Sharif

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Musculoskeletal Pain ◽

Vitamin D Supplementation ◽

High Dose ◽

Single High Dose ◽

Hydroxyvitamin D ◽

Before And After ◽

25 Hydroxyvitamin D ◽

Female Nurses

Purpose: To investigate the effect of weekly single high dose vitamin D supplementation on serum 25-hydroxyvitamin D [25(OH)D], and non-specific musculoskeletal pain in female nurses. Methods: In this prospective study in Kashan/Iran, from April 1, 2014, through September 30, 2014, the 150 nurses with vitamin D deficiency received the weekly pearls of 50,000 units of vitamin D3 for 10 weeks. The serum level of 25(OH)D was measured before and after supplement therapy. The subjects were also asked to complete the Extended Nordic Musculoskeletal Questionnaire. All analyses were conducted with SPSS version 16. Results: After 10 weeks of intervention there was [Formula: see text][Formula: see text]ng/mL increase in 25(OH)D. The 82 nurses (54.7%) had 25(OH)D in normal range, while the 68 nurses (45.3%) were still vitamin D deficient. Weight could explain 15.4% increase in 25(OH)D. Before intervention 135 (90%), of nurses reported musculoskeletal pain in at least one region, after intervention this number decreased to 72.7%. There was a statistically significant improvement in musculoskeletal pain in neck, shoulders, upper back, lower back, hips/tights, knees, and ankles/feet after intervention. Conclusions: The weekly single high dose of vitamin D for 10 weeks could resolve vitamin D deficiency in about half of the patients. Patients with non-specific musculoskeletal pain might benefit from vitamin D supplementation.

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Skeletal and Extraskeletal Actions of Vitamin D: Current Evidence and Outstanding Questions

Endocrine Reviews ◽

10.1210/er.2018-00126 ◽

2018 ◽

Vol 40 (4) ◽

pp. 1109-1151 ◽

Cited By ~ 110

Author(s):

Roger Bouillon ◽

Claudio Marcocci ◽

Geert Carmeliet ◽

Daniel Bikle ◽

John H White ◽

...

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Human Subjects ◽

Osteoporotic Fractures ◽

Vitamin D Supplementation ◽

Current Evidence ◽

Elderly Subjects ◽

Vitamin D Status ◽

Hydroxyvitamin D ◽

25 Hydroxyvitamin D

AbstractThe etiology of endemic rickets was discovered a century ago. Vitamin D is the precursor of 25-hydroxyvitamin D and other metabolites, including 1,25(OH)2D, the ligand for the vitamin D receptor (VDR). The effects of the vitamin D endocrine system on bone and its growth plate are primarily indirect and mediated by its effect on intestinal calcium transport and serum calcium and phosphate homeostasis. Rickets and osteomalacia can be prevented by daily supplements of 400 IU of vitamin D. Vitamin D deficiency (serum 25-hydroxyvitamin D <50 nmol/L) accelerates bone turnover, bone loss, and osteoporotic fractures. These risks can be reduced by 800 IU of vitamin D together with an appropriate calcium intake, given to institutionalized or vitamin D–deficient elderly subjects. VDR and vitamin D metabolic enzymes are widely expressed. Numerous genetic, molecular, cellular, and animal studies strongly suggest that vitamin D signaling has many extraskeletal effects. These include regulation of cell proliferation, immune and muscle function, skin differentiation, and reproduction, as well as vascular and metabolic properties. From observational studies in human subjects, poor vitamin D status is associated with nearly all diseases predicted by these extraskeletal actions. Results of randomized controlled trials and Mendelian randomization studies are supportive of vitamin D supplementation in reducing the incidence of some diseases, but, globally, conclusions are mixed. These findings point to a need for continued ongoing and future basic and clinical studies to better define whether vitamin D status can be optimized to improve many aspects of human health. Vitamin D deficiency enhances the risk of osteoporotic fractures and is associated with many diseases. We review what is established and what is plausible regarding the health effects of vitamin D.

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Are Indian obese children and adolescents at increased risk for Vitamin D deficiency?

Indian Journal of Medical Sciences ◽

10.25259/ijms_510_2020 ◽

2021 ◽

Vol 0 ◽

pp. 1-5

Author(s):

Aashima Dabas ◽

T. Aravind ◽

Sangeeta Yadav ◽

Mukta Mantan ◽

Smita Kaushik

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Vitamin D Supplementation ◽

Obese Children ◽

Indian Children ◽

Hydroxyvitamin D ◽

Increased Risk ◽

High Risk Factor ◽

25 Hydroxyvitamin D ◽

Obese Subjects

Objectives: Obesity has been mentioned as a high risk factor for Vitamin D deficiency (VDD) requiring supplementation in Indian children. Material and Methods: Forty obese and age-matched non-obese subjects (age 5–18 years) were assessed for lifestyle parameters, metabolic profile, and serum 25-hydroxyvitamin D (25OHD). VDD was defined as serum 25OHD < 12 ng/mL. Results: Mean 25OHD was comparable among obese and controls (15.0 ± 9.95 and 15.1 ± 4.79 ng/mL; P = 0.97) with VDD seen in 82% of cases and 85% of controls. Pubertal cases had lower 25OHD values than prepubertal obese cases (10.78 ± 4.69 and 17.2 ± 11 ng/mL; P = 0.06). Mean duration of physical activity (<2 h/week) and screen time (>2 h/day) was similar across prepubertal and pubertal groups and between obese and controls. Obesity was not associated with risk for VDD among cases and controls (odds ratio 0.83, 95% C.I. 0.25–2.7, P = 0.76). Conclusion: Obese pubertal subjects were more at risk for VDD than prepubertal subjects. Routine Vitamin D supplementation to obese Indian children may be considered during adolescence.

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Impact of vitamin D supplementation on health-care use in a 25-hydroxyvitamin D-tested population in France: a population-based descriptive cohort study

Public Health Nutrition ◽

10.1017/s136898001400038x ◽

2014 ◽

Vol 18 (3) ◽

pp. 554-561 ◽

Cited By ~ 1

Author(s):

Pascal Caillet ◽

Susan B Jaglal ◽

Laurent Laforest ◽

Roland Chapurlat ◽

Muriel Rabilloud ◽

...

Keyword(s):

Health Care ◽

Vitamin D ◽

Vitamin D Deficiency ◽

Muscle Relaxant ◽

Vitamin D Supplementation ◽

Insurance Fund ◽

Hydroxyvitamin D ◽

25 Hydroxyvitamin D ◽

The Impact ◽

Health Care Claims

AbstractObjectiveChronic vitamin D deficiency has been associated in some patients with diffuse musculoskeletal pain. These unspecific symptoms may partly explain why vitamin D deficiency is often diagnosed late. Our aim was to analyse health-care claims after vitamin D supplementation in patients likely to have vitamin D deficiency.DesignAmbulatory health-care claims were compared before and after a vitamin D supplementation prescribed following a 25-hydroxyvitamin D assay.SettingHealth Insurance Fund (FHIF) database of the Rhône-Alpes area, France.SubjectsAmong patients reimbursed for a 25-hydroxyvitamin D assay between 1 December 2008 and 31 January 2009, those supplemented with vitamin D after the assay were matched on the date of assay to patients who did not receive vitamin D.ResultsAmong the 3023 patients who had a 25-hydroxyvitamin D assay, 935 were consequently supplemented and matched to 935 patients not supplemented. Their median age was 50·0 and 49·5 years, respectively. Patients supplemented decreased their muscle relaxant consumption whereas no change was observed in the reference group, the difference between the two groups was significant (P=0·03). Second and third Pain Relief Ladder prescriptions decreased in both groups but not significantly differently between groups (P=0·58). There was a decrease in prescriptions of biological examination in both groups with no significant difference.ConclusionsBesides a decrease in muscle relaxant prescriptions in the supplemented group, it was difficult to assess the impact of vitamin D supplementation in patients likely to have vitamin D deficiency. Prospective cohort studies and randomized trials are needed to assess the efficiency of screening and supplementing vitamin D deficiency.

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Significant Independent Predictors of Vitamin D Deficiency in Inpatients and Outpatients of a Nephrology Unit

International Journal of Endocrinology ◽

10.1155/2013/237869 ◽

2013 ◽

Vol 2013 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Recep Bentli ◽

Hulya Taskapan ◽

Halil Toktaş ◽

Ozkan Ulutas ◽

Adnan Ozkahraman ◽

...

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Female Gender ◽

Vitamin D Insufficiency ◽

Vitamin D Supplementation ◽

Documentary Evidence ◽

Hydroxyvitamin D ◽

Nitrogen Levels ◽

25 Hydroxyvitamin D ◽

Higher Doses

Aims. Kidney disease was found to be a major risk factor for vitamin D deficiency in a population study of patients hospitalized. The aims of the study were to describe the prevalence of vitamin D deficiency inpatients and outpatients in a nephrology department during fall and to evaluate effect of assessing serum 25-hydroxyvitamin D (25(OH)D) levels and previous supplementation of cholecalciferol on vitamin D status.Methods. We studied 280 subjects in total, between October and January. The subjects were recruited from the following two groups: (a) inpatients and (b) outpatients in nephrology unit. We examined previous documentary evidence of vitamin D supplementation of the patients.Results. The prevalence of vitamin D deficiency among these 280 patients was 62,1% (174 patients). Fifty-three patients (18.9%) had severe vitamin D deficiency, 121 patients (43.2%) moderate vitamin D deficiency, and 66 patients (23.6%) vitamin D insufficiency. In logistic regression analysis female gender, not having vitamin D supplementation history, low serum albumin, and low blood urea nitrogen levels were significant independent predictors of vitamin D deficiency while no association of vitamin D deficiency with diabetes mellitus, serum creatinine, eGFR, and being hospitalized was found.Conclusion. Vitamin D deficiency, seems to be an important problem in both inpatients and outpatients of nephrology. Monitoring serum 25(OH)D concentrations regularly and replacement of vitamin D are important. Women in Turkey are at more risk of deficiency and may therefore need to consume higher doses of vitamin D.

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Effects of Moderate Sun Exposure and Vitamin D Supplementation on Serum 25-Hydroxyvitamin D Concentration Among Malay Women

Current Developments in Nutrition ◽

10.1093/cdn/nzab059_005 ◽

2021 ◽

Vol 5 (Supplement_2) ◽

pp. 1304-1304

Author(s):

Norliyana Aris ◽

Hamid Jan Bin Jan Mohamed ◽

Wan Mohd Izani Bin Wan Mohamed

Keyword(s):

Vitamin D ◽

Placebo Group ◽

Vitamin D Deficiency ◽

Sun Exposure ◽

Vitamin D Supplementation ◽

Dietary Vitamin ◽

Hydroxyvitamin D ◽

25 Hydroxyvitamin D ◽

Hands And Feet ◽

Vitamin D Supplement

Abstract Objectives Known as ‘sunshine vitamin’, sun exposure is a major and natural source of vitamin D. This study aimed to investigate the effects of moderate sun exposure and vitamin D supplementation on vitamin D concentration among Malay women in Kelantan, Malaysia. Methods A quasi-experimental study design was carried out among female indoor workers with vitamin D deficiency (serum 25-hydroxyvitamin D < 50 nmol/l) for 12 weeks to evaluate the effects of moderate sun exposure (n = 19; 15 minutes sun exposure biweekly on face, lower arms, hands and feet), vitamin D supplementation (n = 15; 50 000 IU cholecalciferol weekly) and placebo (n = 15) on serum 25-hydroxyvitamin D (25(OH)D) levels. Data was collected twice from each respondent, firstly during baseline and secondly during endpoint. Body composition measurements (body fat percentage and body mass index), fasting blood test (serum 25(OH)D level) and questionnaire (socio-demographic, physical activity and dietary vitamin D intake) were conducted. The vitamin D classification was based on the 2011 Endocrine Society Clinical Practice Guidelines. Repeated measure ANOVA within group analysis was applied. Results The baseline characteristics did not differ significantly among study groups except for age (F = 6.15, p = 0.004). After 12 weeks, serum 25(OH)D levels increased significantly in sun exposure (mean difference (MD) = 14.27 nmol/l, p < 0.001) and vitamin D supplement group (MD = 14.30 nmol/l, p < 0.001) but not in the placebo group (MD = 1.63 nmol/l, p = 0.067). Conclusions The 12-weeks intervention with moderate sun exposure and vitamin D supplementation showed a similar significant increment in serum 25(OH)D levels. However, no changes in serum 25(OH)D was observed in the placebo group. These results showed that sunlight exposure and vitamin D supplement were equally helpful in improving serum 25(OH)D levels in participants with vitamin D deficiency. Funding Sources Short Term Research Grant, Universiti Sains Malaysia.

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The combined presence of hypertension and vitamin D deficiency increased the probability of the occurrence of small vessel disease in China

10.21203/rs.2.9138/v1 ◽

2019 ◽

Author(s):

Junzeng Si ◽

kuibao li ◽

peiyan shan ◽

Junliang Yuan

Keyword(s):

Blood Pressure ◽

Vitamin D ◽

Vitamin D Deficiency ◽

Small Vessel Disease ◽

Vitamin D Supplementation ◽

Small Vessel ◽

Stroke Patients ◽

Hydroxyvitamin D ◽

Vessel Disease ◽

25 Hydroxyvitamin D

Abstract Background: The exact relationship between 25-hydroxyvitamin D [25(OH) D] levels and small vessel disease (SVD) are not clear in China. The aim of this study was to determine the association between 25(OH) D and SVD in China. Methods: We enrolled consecutive 106 patients with SVD and 115 controls in Beijing Chaoyang Hospital and Jinan City people’s hospital between Jan 2017 and Dec 2017. Vitamin D status was estimated by measuring serum 25-hydroxyvitamin D [25(OH) D]. The subjects were categorized into three subgroups: vitamin D deficiency (≤12ng/ml), insufficiency (12-20ng/ml) and sufficiency (≥20 ng/ml). Results: Among 106 stroke patients, 80 (75.5%) were men and mean age was 61.6±13.2 years. 25(OH) D deficiency was observed in 76 (71.7%) stroke patients and 47 (40.9%) controls (P=0.001). Comparing with controls, patients with SVD were correlated with higher proportion of male, the histories of stroke, smoking and hyperlipidemia; higher systolic blood pressure, diastolic blood pressure and low density lipoprotein; lower of 25(OH)D level. The logistic regression analysis showed the level of 25(OH)D was independently predicted the occurrence of SVD (OR 0.772, CI 0.691-0.862, P=0.001). Compared with those in sufficiency group (≥20ng/ml), the ORs of SVD in the deficiency (≤12ng/ml) and insufficiency group (12–20 ng/ml) of 25(OH)D were 5.609 [95% confidence interval (CI) 2.006-15.683] and 1.077 (95% CI: 0.338-3.428) after adjusting for potential confounders, respectively. We also found a significant effect modification of SVD risk by 25(OH)D status and hypertension interaction (P=0.001), and compared with those with sufficiency 25(OH)D levels, in hypertensives with vitamin D deficiency (≤12ng/ml) and insufficiency (12-20 ng/ml), the ORs were increased to 9.738 (2.398-39.540) and 1.108 (0.232-5.280), respectively (Pinteraction=0.001). Conclusion: Our findings showed patients with SVD were correlated with the deficiency of 25(OH)D. The combined presence of hypertension and vitamin D deficiency increased the probability of developing SVD. Our study raises the importance that vitamin D supplementation combined with monitoring hypertension are promising approaches in the management of SVD.

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Vitamin D Toxicity Managed with Peritoneal Dialysis

Case Reports in Endocrinology ◽

10.1155/2021/9912068 ◽

2021 ◽

Vol 2021 ◽

pp. 1-6

Author(s):

Krystel Feghali ◽

Kostas Papamarkakis ◽

Jackson Clark ◽

Neha Malhotra ◽

Lanu Stoddart ◽

...

Keyword(s):

Vitamin D ◽

Peritoneal Dialysis ◽

Case Report ◽

Vitamin D Deficiency ◽

Kidney Injury ◽

Vitamin D Supplementation ◽

Hydroxyvitamin D ◽

Severe Hypercalcemia ◽

Risk Of Cancer ◽

Vitamin D Toxicity

Vitamin D deficiency is a global health issue that afflicts more than one billion children and adults worldwide. Vitamin D supplementation has increased over the years, whether through medical prescriptions, over-the-counter, or online purchasing. This is driven by a more recognized association between vitamin D sufficiency status and lower risk of cancer. In addition, more recently, it is used as a potential prophylactic and treatment for COVID-19 infection. This can lead to toxicity from overingestion. While rare, it has been reported in the literature. In this case report, we present a 75-year-old man with severe hypercalcemia secondary to vitamin D toxicity managed with peritoneal dialysis. He presented with biochemical evidence of hypercalcemia, acute kidney injury, and pancreatitis. Workup for his hypercalcemia led to the diagnosis of vitamin D toxicity as shown by a level greater than 200 ng/dL (Ref: 20–50 ng/mL) was confirmed by liquid chromatography-mass spectroscopy. Cornerstone medical management of hypercalcemia was provided which included aggressive intravenous fluid hydration, intravenous diuretics, calcitonin, bisphosphonate, and corticosteroid therapy. At every interruption of therapy, calcium levels trended upward. A thorough literature review yielded the finding of a sole case report from 1966 presented at the Third International Congress of Nephrology, in which peritoneal dialysis was used in the management of vitamin D toxicity and hypercalcemia. This modality is established to cause vitamin D deficiency. In collaboration with the nephrology team, 10 sessions of peritoneal dialysis were undertaken with resolution of hypercalcemia and downtrend in 25-hydroxyvitamin D levels as measured by dilution.

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Vitamin D Metabolism and Guidelines for Vitamin D Supplementation

10.33176/aacb-20-00006 ◽

2020 ◽

Vol 41 (3) ◽

pp. 103-126

Author(s):

Indra Ramasamy

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Vitamin D Supplementation ◽

Vitamin D Status ◽

Vitamin D Metabolism ◽

Hydroxyvitamin D ◽

Response Data ◽

Vitamin D Intake ◽

25 Hydroxyvitamin D ◽

Significant Health

Vitamin D is essential for bone health and is known to be involved in immunomodulation and cell proliferation. Vitamin D status remains a significant health issue worldwide. However, there has been no clear consensus on vitamin D deficiency and its measurement in serum, and clinical practice of vitamin D deficiency treatment remains inconsistent. The major circulating metabolite of vitamin D, 25-hydroxyvitamin D (25(OH)D), is widely used as a biomarker of vitamin D status. Other metabolic pathways are recognised as important to vitamin D function and measurement of other metabolites may become important in the future. The utility of free 25(OH)D rather than total 25(OH)D needs further assessment. Data used to estimate the vitamin D intake required to achieve a serum 25(OH)D concentration were drawn from individual studies which reported dose-response data. The studies differ in their choice of subjects, dose of vitamin D, frequency of dosing regimen and methods used for the measurement of 25(OH)D concentration. Baseline 25(OH)D, body mass index, ethnicity, type of vitamin D (D2 or D3) and genetics affect the response of serum 25(OH)D to vitamin D supplementation. The diversity of opinions that exist on this topic are reflected in the guidelines. Government and scientific societies have published their recommendations for vitamin D intake which vary from 400–1000 IU/d (10–25 µg/d) for an average adult. It was not possible to establish a range of serum 25(OH)D concentrations associated with selected non-musculoskeletal health outcomes. To recommend treatment targets, future studies need to be on infants, children, pregnant and lactating women.

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