Hormonal profile of survivors of breast cancer with fatigue: A pilot study

Background & objectives: One of the most common problems experienced by breast cancer survivors (BCSs) is fatigue. There has been little research about the status of hormones in breast cancer patients as an aetiology of cancer-related fatigue (CRF). Hence, a pilot study was conducted to assess the levels of hormones such as thyroid, cortisol, dehydroepiandrosterone sulphate (DHEAS), oestrogen and progesterone in BCSs with fatigue. Methods: BCSs with complaints of fatigue were assessed using the Brief Fatigue Inventory (BFI) tool and evaluation of the hormone profiles was done in moderate-to-severe fatigued survivors. Data collected were analyzed to look for any association between fatigue and altered hormonal levels. Results: In this study, 56 per cent (n=62) of survivors experienced moderate-to-severe fatigue out of 110 patients reporting fatigue. Thyroid functions were deranged in 22 patients (35.48%). The thyroid stimulating hormone (TSH) levels were found to have a significant negative association with the severity of fatigue, (P<0.05). Twelve patients (19.35%) had reduced DHEAS levels suggestive of impaired hormone synthesis in the adrenal gland. Twenty two postmenopausal survivors (35.48%) had raised oestradiol levels. Interpretation & conclusions: The findings of this study suggest that the hormonal milieu, especially thyroid hormone and DHEAS may have a role in CRF experienced by BCSs and needs further exploration.

Sunlight Exposure vs Oral Vitamin D Supplementation for Prevention of Vitamin D Deficiency in Infancy: ARandomized Controlled Trial

Objective: To compare the efficacy of sunlight exposure and oral vitamin D3 supplementation to achieve vitamin D sufficiency in infants at 6 months of age. Design: Open-label randomized controlled trial. Setting: Public hospital in Northern India (28.7°N). Participant: Breastfed infants at 6-8 weeks of age. Intervention: Randomized to receive sunlight exposure (40% body surface area for a minimum of 30 minutes/week) or oral vitamin D3 supplementation (400 IU/day) till 6 months of age. Outcome: Primary - proportion of infants having vitamin D sufficiency (>20 ng/mL). Secondary - proportion of infants developing vitamin D deficiency (<12ng/mL) and rickets in both the groups at 6 months of age. Results: Eighty (40 in each group) infants with mean (SD) age 47.8 (4.5) days were enrolled. The proportion of infants with vitamin D sufficiency increased after intervention in the vitamin D group from 10.8% to 35.1% (P=0.01) but remained the same in sunlight group (13.9%) and was significant on comparison between both groups (P=0.037). The mean (SD) compliance rate was 72.9 (3.4)% and 59.7 (23.6)% in the vitamin D and sunlight group, respectively (P=0.01). The geometric mean (95% CI) serum 25(OH) D levels in the vitamin D and sunlight group were 16.23 (13.58-19.40) and 11.89 (9.93-14.23) ng/mL, respectively; (P=0.02), after adjusting baseline serum 25(OH)D with a geometric mean ratio of 1.36 (1.06-1.76). Two infants in sunlight group developed rickets. Conclusion: Oral vitamin D3 supplementation is more efficacious than sunlight in achieving vitamin D sufficiency in breastfed infants during the first 6 months of life due to better compliance.

Seasonal Variation in Serum 25-hydroxy Vitamin D and its Association with Clinical Morbidity in Healthy Infants from Northern India

Objective: To evaluate the seasonal change in serum 25-hydroxyvitamin D (25-OHD) level inhealthy infants and to relate it to common childhood morbidities. Methods: 72 healthybreastfed infants residing in Delhi were enrolled at the end of summer and followed till the endof winter [mean (SD) duration 200 (10) d]. Serum 25-OHD was estimated at baseline andfollow-up. Infants were monitored for common childhood diseases. Results: Mean (SD)serum 25-OHD level was lower at the end of winter (20.7 (8.02) ng/mL) than summer (22.9(8.70) ng/mL) [mean difference (95% CI) –2.14 ng/mL (–3.36, –1.06), P<0.001). Theseasonal distribution of children according to vitamin D status in summer and winter -Deficient(15.3%, 12.5%), Insufficient (19.4%, 30.6%) and Sufficient(65.3%, 56.9%),respectively was comparable P=0.17). The morbidity profile remained unaffected by changein vitamin D status from summer to winter. Conclusions: Seasonal changes in vitamin Dlevels do not have significant clinical effect or effect on overall vitamin D status in apparentlyhealthy infants from North India. This may have implications for results of population surveysfor vitamin D status, irrespective of the season when they are conducted.

Vitamin D Supplementation for Treatment and Prevention of Pneumonia in Under-five Children: A Randomized Double-blind Placebo Controlled Trial.

Objective: To evaluate the efficacy of single oral mega-dose of Vitamin D3 for treatment and prevention of pneumonia in under-five children. Design: Randomized, double blind, placebo-controlled trial. Setting: Tertiary-care hospital. Participants: 324 children (of 980 assessed) between 6 mo-5 y age (median (IQR): 12 (7,19.8) mo) with WHO-defined severe pneumonia. Of these, 126 (39%) were vitamin D deficient (serum 25(OH)D <12 ng/mL). Intervention: 100,000 IU of oral cholecalciferol (n= 162) or placebo (n= 162) in single dose, administered at enrolment. Outcome variables: Primary: Time to resolution of severe pneumonia and proportion of children having recurrence of pneumonia in next 6 months; Secondary: Change in serum levels of 25(OH)D; immunoglobulins IgA, IgG, IgM, and cathelicidin 2 weeks following supplementation; and time taken for overall resolution of illness. Results: Median (95% CI) time for resolution of severe pneumonia was 30 (29, 31) h in the vitamin D group as compared to 31 (29,33) h in the placebo group [adjusted hazard ratio (95% CI): 1·39 (1·11, 1·76); P=0·005]. The risk of recurrence of pneumonia in next 6 months was comparable in the two groups [placebo: 36/158 (22·8%); vitamin D: 39/156 (25%); RR (95% CI): 1·13 (0·67,1·90); P=0·69]. Proportion of vitamin D deficient children declined from 38% to 4% in the supplementation group, and from 41% to 33% in the placebo group, two weeks after supplementation. There was no significant effect of vitamin D supplementation on serum levels of cathelicidin, IgA and IgG. The time taken for complete recovery from pneumonia, duration of hospitalization, and fever clearance time were comparable for the two groups. No adverse event was noted related to the intervention. Conclusion: There is no robust evidence of a definite biological benefit, either for therapy or prevention, to suggest a routine megadose supplement of vitamin D3 for under-five children with severe pneumonia.