Rationale and Design of Khuzestan Vitamin D Deficiency Screening Program in Pregnancy: A Stratified Randomized Vitamin D Supplementation Controlled Trial

Abstract Fibromyalgia is a debilitating chronic condition which poses a therapeutic challenge to the clinician. With a large backlog in patient flow subsequent to the COVID-19 pandemic and rising numbers of patients with post-acute sequelae of COVID-19 (PASC) presenting with fibromyalgia-like clinical features, there is an increasingly pressing need to identify broad cost-effective interventions. Low levels of vitamin D have previously been reported in patients with fibromyalgia, though any causative link has been difficult to establish. A systematic literature review on the association between vitamin D deficiency and fibromyalgia was performed examining retrospective evidence both for and against an association between vitamin D deficiency (VDD) and fibromyalgia and evaluating the therapeutic benefit from supplementation. A group of six studies were selected based on relevance, use of controls, quality of research and citations. Four primary studies assessing the prevalence of VDD in fibromyalgia patients versus controls were evaluated with a total 3,496 subjects. Three included females only and one larger study assessed males. Two (n = 313) concluded the presence of a statistically significant association, and two (n = 161) found none. Two randomised controlled trials assessing the effect of vitamin D supplementation in a total of 80 subjects found conflicting results, with pain reduction in one and none in the other. It is likely there exists an association between VDD deficiency and fibromyalgia in a large subset of patients, although establishing primary causation is difficult. There is a need for larger randomised controlled trial designs with more effective comparison with healthy subjects and control for confounding factors. Given VDD is a major problem in the general population, we recommend supplementation be recommended by healthcare professionals to fibromyalgia patients for the purpose of maintaining bone health given their potentially increased susceptibility to developing deficiency and its sequelae.

Download Full-text

Effect of vitamin D supplementation on growth parameters of children with vitamin D deficiency: a community based randomized controlled trial

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20174733 ◽

2017 ◽

Vol 4 (6) ◽

pp. 2070

Author(s):

Sagul R. Mugunthan ◽

Yashwant K. Rao ◽

Tanu Midha ◽

Anurag Bajpai

Keyword(s):

Vitamin D ◽

Alkaline Phosphatase ◽

Vitamin D Deficiency ◽

Growth Parameters ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Community Based ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Background: Vitamin D deficiency remains the most common cause of rickets globally and is highly prevalent in developing countries including India. This study aimed to compare the efficacy of vitamin D and calcium together with calcium alone on growth parameters of children with vitamin D deficiency in community based setting.Methods: A randomized controlled trial was conducted in community based setting in Kanpur district. Multistage random sampling technique was used to select a total of 395 children between 2 years to 5 years from 5 villages of block Vidhunu. Of these, 138 children were randomized into two groups using balanced block randomization technique. Group 1 received vitamin D with calcium together and group 2 received calcium alone for a period of 12 months. Anthropometry, serum vitamin D, calcium, alkaline phosphatase levels were estimated at baseline and after 12 months. Data was analyzed using SPSS 20. Student’s t test was used to analyze the differences in growth and laboratory parameters in the two groups. Multiple linear regression analysis was used to assess the effect of various factors on the growth parameters.Results: Prevalence of vitamin D deficiency was 78.7%. Baseline characteristics of both groups were similar. After 12 months, group 1 demonstrated significantly greater improvement in weight SD score (21.4%) and height SD score (10.3%) and growth velocity (9.1 cm/year) compared to group 2 (14.3%, 7.8% and 6.9 cm/ year respectively). Also subjects in group 1 showed significantly greater improvement in serum levels of vitamin D, calcium and alkaline phosphatase than group 2.Conclusions: Vitamin D supplementation along with calcium improves the growth of children. Regular supplementation of all children with vitamin D can be considered as a policy for prevention of malnutrition.

Download Full-text

Association of Bacterial Vaginosis with Vitamin D in Pregnancy: Secondary Analysis from the Kellogg Pregnancy Study

American Journal of Perinatology Reports ◽

10.1055/s-0039-1693163 ◽

2019 ◽

Vol 09 (03) ◽

pp. e226-e234

Author(s):

Anna Maya Powell ◽

Judy R. Shary ◽

Christopher Louden ◽

Vishwanathan Ramakrishnan ◽

Allison Ross Eckard ◽

...

Keyword(s):

Vitamin D ◽

Bacterial Vaginosis ◽

Vitamin D Deficiency ◽

Pregnancy Outcomes ◽

Controlled Trial ◽

Secondary Analysis ◽

Hydroxyvitamin D ◽

Gram Staining ◽

Mixed Regression ◽

In Pregnancy

Objective Bacterial vaginosis (BV) is associated with vitamin D deficiency and poor pregnancy outcomes. We studied a nested cohort from a randomized controlled trial to investigate the association between BV and vitamin D concentration in pregnancy. Study Design Subjects with randomly assigned 400 versus 4,400 IU of daily cholecalciferol (vitamin D3) had vaginal swabs collected for Gram staining and Nugent score calculation, as well as plasma 25-hydroxyvitamin D (25(OH)D) measurement at three pregnancy time points. Results Fifty-two (21.2%) of the 245 women included in the analysis were diagnosed with BV at study entry. Women with BV were also more likely to be African American (p < 0.0001) and have lower 25(OH)D concentrations at 22 to 24 weeks' gestation (p = 0.03). There were no differences in pregnancy outcomes of interest within this group compared with the remaining study subjects. In mixed regression modeling, while race (p = 0.001) and age (p = 0.03) were significant predictors of BV prevalence independently, 25(OH)D concentration (p = 0.81), gestational age (p = 0.06), and body mass index (p = 0.87) were not. Conclusion Neither vitamin D deficiency in early pregnancy nor supplementation decreased BV incidence during pregnancy. Pregnancy outcomes (preterm birth and hypertensive disorders of pregnancy) were similar among women with and without BV.

Download Full-text

The Effect of High-Dose Postpartum Maternal Vitamin D Supplementation Alone Compared with Maternal Plus Infant Vitamin D Supplementation in Breastfeeding Infants in a High-Risk Population. A Randomized Controlled Trial

Nutrients ◽

10.3390/nu11071632 ◽

2019 ◽

Vol 11 (7) ◽

pp. 1632 ◽

Cited By ~ 12

Author(s):

Adekunle Dawodu ◽

Khalil M. Salameh ◽

Najah S. Al-Janahi ◽

Abdulbari Bener ◽

Naser Elkum

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Serum Calcium ◽

Vitamin D3 ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Urine Calcium ◽

Randomized Controlled ◽

High Prevalence ◽

Maternal Supplementation

In view of continuing reports of high prevalence of severe vitamin D deficiency and low rate of infant vitamin D supplementation, an alternative strategy for prevention of vitamin D deficiency in infants warrants further study. The aim of this randomized controlled trial among 95 exclusively breastfeeding mother–infant pairs with high prevalence of vitamin D deficiency was to compare the effect of six-month post-partum vitamin D3 maternal supplementation of 6000 IU/day alone with maternal supplementation of 600 IU/day plus infant supplementation of 400 IU/day on the vitamin D status of breastfeeding infants in Doha, Qatar. Serum calcium, parathyroid hormone, maternal urine calcium/creatinine ratio and breast milk vitamin D content were measured. At baseline, the mean serum 25-hydroxyvitamin D (25(OH)D) of mothers on 6000 IU and 600 IU (35.1 vs. 35.7 nmol/L) and in their infants (31.9 vs. 29.6) respectively were low but similar. At the end of the six month supplementation, mothers on 6000 IU achieved higher serum 25(OH)D mean ± SD of 98 ± 35 nmol/L than 52 ± 20 nmol/L in mothers on 600 IU (p < 0.0001). Of mothers on 6000 IU, 96% achieved adequate serum 25(OH)D (≥50 nmol/L) compared with 52%in mothers on 600 IU (p < 0.0001). Infants of mothers on 600 IU and also supplemented with 400 IU vitamin D3 had slightly higher serum 25(OH)D than infants of mothers on 6000 IU alone (109 vs. 92 nmol/L, p = 0.03); however, similar percentage of infants in both groups achieved adequate serum 25(OH)D ≥50 nmol/L (91% vs. 89%, p = 0.75). Mothers on 6000 IU vitamin D3/day also had higher human milk vitamin D content. Safety measurements, including serum calcium and urine calcium/creatinine ratios in the mother and serum calcium levels in the infants were similar in both groups. Maternal 6000 IU/day vitamin D3 supplementation alone safely optimizes maternal vitamin D status, improves milk vitamin D to maintain adequate infant serum 25(OH)D. It thus provides an alternative option to prevent the burden of vitamin D deficiency in exclusively breastfeeding infants in high-risk populations and warrants further study of the effective dose.

Download Full-text