Effect of Vitamin D on Thyroid Autoimmunity: A Randomized, Double-Blind, Controlled Trial Among Ethnic Minorities.

CONTEXT: Autoimmune thyroid disorders have been linked to vitamin D deficiency, but an effect of vitamin D supplementation is not established. OBJECTIVE: Our objective was to test whether vitamin D compared with placebo could reduce thyroid autoantibodies. DESIGN: Predefined additional analyses from a randomized, double-blind, placebo-controlled trial. SETTING: The study was conducted in different community centers in Oslo, Norway. PARTICIPANTS: A total of 251 presumed healthy men and women, aged 18 to 50 years, with backgrounds from South Asia, the Middle East, and Africa were included. INTERVENTION: Daily supplementation with 25 µg (1000 IU) vitamin D3, 10 µg (400 IU) vitamin D3, or placebo for 16 weeks. OUTCOME MEASURE: Difference in preintervention and postintervention antithyroid peroxidase antibody (TPOAb) levels. Additional outcomes were differences in thyroid-stimulating hormone (TSH) and free fraction of thyroxine (fT4). RESULTS: There were no differences in change after 16 weeks on TPOAb (27 kU/L; 95% CI, -17 to 72; P = 0.23), TSH (-0.10 mU/L; 95% CI, -0.54 to 0.34; P = 0.65), or fT4 (0.09 pmol/L; 95% CI, -0.37 to 0.55; P = 0.70) between those receiving vitamin D supplementation or placebo. Mean serum 25(OH)D3 increased from 26 to 49 nmol/L in the combined supplementation group, but there was no change in the placebo group. CONCLUSION: Vitamin D3 supplementation, 25 µg or 10 µg, for 16 weeks compared with placebo did not affect TPOAb level in this randomized, double-blind study among participants with backgrounds from South Asia, the Middle East, and Africa who had low vitamin D levels at baseline.

Vitamin D levels during pregnancy and associations with birth weight and body composition of the newborn: a longitudinal multiethnic population-based study.

We investigated associations between serum 25-hydroxyvitamin D (25(OH)D) in pregnancy and birth weight and other neonatal anthropometric measures. The present study was a population-based, multiethnic cohort study of 719 pregnant women (59 % ethnic minorities) in Oslo, Norway, delivering a singleton neonate at term and with birth weight measurements. In a representative sample, anthropometric measurements were taken. Maternal 25(OH)D was measured at gestational weeks 15 and 28. Women with 25(OH)D <37 nmol/l were recommended vitamin D3 supplementation. Separate linear regression analyses were performed to model the associations between 25(OH)D and each of the outcomes: birth weight, crown-heel length, head circumference, abdominal circumference, sum of skinfolds, mid-upper arm circumference and ponderal index. In early pregnancy, 51 % of the women were vitamin D deficient (25(OH)D<50 nmol/l). In univariate analyses and in models adjusting for maternal age, parity, education, prepregnancy BMI, season, gestational age and neonate sex, maternal 25(OH)D was significantly associated with birth weight, head circumference, abdominal circumference and ponderal index (P<0·05 for all), when used as a continuous variable and categorised (consistently low, consistently high, increasing and decreasing level). However, after adjusting for ethnicity, 25(OH)D was no longer associated with any of the outcomes. Sex-specific associations for abdominal circumference and sum of skinfolds were found (P for interaction<0·05). In conclusion, in a multiethnic cohort of pregnant women with high prevalence of vitamin D deficiency, we found no independent relation between maternal vitamin D levels and any of the neonatal anthropometric measures, and the strong association between ethnicity and neonatal outcomes was not affected by maternal vitamin D status.

Effect of vitamin D3 supplementation on iron status: a randomized, double-blind, placebo-controlled trial among ethnic minorities living in Norway.

BACKGROUND: Both vitamin D and iron deficiencies are widespread globally, and a relationship between these deficiencies has been suggested. However, there is a paucity of randomised controlled trials assessing the effect of vitamin D supplementation on iron status. PURPOSE: We aimed to investigate whether 16 weeks of daily vitamin D3 supplementation had an effect on serum ferritin, haemoglobin, serum iron and transferrin saturation. METHODS: Overall, 251 participants from South Asia, Middle East and Africa aged 18-50 years who were living in Norway were randomised to receive daily oral supplementation of 10 µg vitamin D3, 25 µg vitamin D3, or placebo for 16 weeks during the late winter. Blood samples from baseline and after 16 weeks were analysed for serum 25-hydroxyvitamin D (s-25(OH) D), serum ferritin, haemoglobin and serum iron. In total, 214 eligible participants completed the intervention (86 % of those randomised). Linear regression analysis were used to test the effect of vitamin D3 supplementation combined (10 or 25 µg) and separate doses 10 or 25 µg compared to placebo on change (T2-T1) in each outcome variable adjusted for baseline s-25(OH)D values. RESULTS: There was no difference in change in the levels of s-ferritin (1.9 µg/L, 95 % CI: -3.2, 7.0), haemoglobin (-0.02 g/dL, 95 % CI: -0.12, 0.09), s-iron (0.4 µg/L, 95 % CI: -0.5, 1.3) or transferrin saturation (0.7 %, 95 % CI: -0.6.1, 2.0) between those receiving vitamin D3 or those receiving placebo. Serum 25-hydroxyvitamin D increased from 29 nmol/L at baseline to 49 nmol/L after the intervention, with little change in the placebo group. CONCLUSIONS: In this population of healthy ethnic minorities from South Asia, the Middle East and Africa who had low vitamin D status, 16 weeks of daily supplementation with 10 or 25 µg of vitamin D3 did not significantly affect the haemoglobin levels or other markers of iron status.

Vitamin D deficiency and supplementation in pregnancy in a multiethnic population-based cohort.

BACKGROUND: To investigate ethnic differences in vitamin D levels during pregnancy, assess risk factors for vitamin D deficiency and explore the effect of vitamin D supplementation in women with deficiency in early pregnancy. METHODS: This is a population-based, multiethnic cohort study of pregnant women attending Child Health Clinics for antenatal care in Oslo, Norway. Serum-25-hydroxyvitamin D [25(OH)D] was measured in 748 pregnant women (59% ethnic minorities) at gestational weeks (GW) 15 (SD:3.6) and 28 (1.4). Women with 25(OH)D <37 nmol/L at GW 15 were for ethical reasons recommended vitamin D3 supplementation. Main outcome measure was 25(OH)D, and linear regression models were performed. RESULTS: Severe deficiency (25(OH)D <25 nmol/L) was found at GW 15 in 45% of women from South Asia, 40% from the Middle East and 26% from Sub-Saharan Africa, compared to 2.5% in women from East Asia and 1.3% of women from Western Europe. Women from South Asia, the Middle East and Sub-Saharan Africa had mean values that were -28 (95 % CI:-33, -23), -24 (-29, -18) and -20 (-27, -13) nmol/L lower than in Western women, respectively. Ethnicity, education, season and intake of vitamin D were independently associated with 25(OH)D. At GW 28, the mean 25(OH)D had increased from 23 (SD:7.8) to 47 (27) nmol/L (p < 0.01) in women who were recommended vitamin D supplementation, with small or no change in women with sufficient vitamin D levels at baseline. CONCLUSIONS: Vitamin D deficiency was prevalent among South Asian, Middle Eastern and African women. The serum levels of 25(OH)D increased significantly from GW 15 to 28 in vitamin D deficient women who received a recommendation for supplementation. This recommendation of vitamin D supplementation increased vitamin D levels in deficient women.

Effect of vitamin D3-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway.

OBJECTIVE: Vitamin D is essential for the maintenance of calcium homeostasis and bone mineralization; and low serum 25-hydroxyvitamin D (s-25-(OH)D) concentrations are associated with increased bone turnover. However, there is a lack of randomized controlled trials that have investigated the effect of vitamin D treatment on bone turnover in immigrant populations. We aimed to investigate the effect of 16-week daily vitamin D3 supplementation on bone formation marker serum procollagen type 1 amino-terminal propeptide (P1NP) and bone resorption marker C-terminal crosslinked telopeptide of type I collagen (CTX). DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: Immigrant community centers in Oslo, Norway. PARTICIPANTS: 251 healthy adults aged 18-50 years with a non-Western immigrant background were recruited. INTERVENTION: 16 weeks of daily oral supplementation with either 10 µg vitamin D3, 25 µg vitamin D3, or placebo. MAIN OUTCOME MEASURES: Difference in change during the 16-week intervention between the intervention groups combined (10 or 25 µg of vitamin D3/day) and placebo, in serum P1NP and serum CTX. RESULTS: A total of 214 (85%) participants completed the study. S-25-(OH)D increased from 29 nmol/L at baseline to 49 nmol/L in the intervention group with no significant change in the placebo group. However, there was no difference in change of serum P1NP (mean difference: - 1.2 µg/L (95% CI: - 5.4, 2.9, P = 0.6)) and serum CTX (mean difference: - 0.005 µg/L (95% CI: - 0.03, 0.02, P = 0.7)) between those receiving vitamin D3 supplementation compared with placebo. The plasma PTH had decreased by a mean of - 1.97 pmol/L (95% CI: - 2.7, - 1.3, P < 0.0001) in the vitamin D3 group compared to placebo. CONCLUSIONS: Supplementation with 10 or 25 µg oral vitamin D3 during winter and spring for 16 weeks did not significantly affect serum P1NP and serum CTX, despite increasing s-25(OH)D and decreasing PTH in a healthy immigrant population with low baseline vitamin D status. Trial registration number: NCT01263288.

Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway.

OBJECTIVE: Despite the suggested role of vitamin D in the prevention of diabetes and cardiovascular disease or its risk factors, the evidence is not consistent and there is a paucity of randomized controlled trials in this field. We aimed to investigate the effect of 16-week daily vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, body mass index (BMI), and serum lipids. DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: Immigrant community centers in Oslo, Norway. PARTICIPANTS: 251 healthy adults aged 18-50 years with a non-Western immigrant background. All participants performed the baseline test and 215 (86%) returned to the follow-up test. INTERVENTION: 16 weeks of daily oral supplementation with either 10 µg vitamin D3, 25 µg vitamin D3, or placebo. MAIN OUTCOME MEASURES: Difference in absolute change during the 16-week intervention between the intervention groups combined (10 or 25 µg of vitamin D3/day) and placebo, in HbA1c, fructosamine, serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), and BMI. RESULTS: A total of 215 (86%) participants completed the study. Serum 25-hydroxyvitamin D increased from 29 nmol/L at baseline to 49 nmol/L after intervention, with little change in the placebo group. However, there was no difference in change of HbA1c between those receiving vitamin D3 compared with placebo (mean difference: 0.01% (95% CI -0.04 to 0.06, p=0.7)). Neither did the vitamin D3 supplementation have any effect on the other end points: fructosamine, serum lipids, and BMI. CONCLUSIONS: 16-week vitamin D3 supplementation to healthy immigrants from South Asia, the Middle East, or Africa and now living in Norway with low vitamin D status did not improve HbA1c, fructosamine, lipid profiles, or BMI. An updated meta-analysis of similar published trials showed that our results were generally consistent with those of other studies. TRIAL REGISTRATION NUMBER: NCT01263288.

Effect of vitamin D on musculoskeletal pain and headache: A randomized, double-blind, placebo-controlled trial among adult ethnic minorities in Norway.

Immigrants from South Asia, the Middle East, and Africa living in Northern Europe frequently have low vitamin D levels and more pain compared to the native Western population. The aim of this study was to examine whether daily vitamin D3 (25 µg/d or 10 µg/d) supplementation for 16 weeks would improve musculoskeletal pain or headache compared to placebo. This randomized, double-blind, placebo-controlled, parallel-group trial recruited 251 participants aged 18 to 50 years, and 215 (86%) attended the follow-up visit. The pain measures were occurrence, anatomical localization, and degree of musculoskeletal pain, as measured by visual analogue scale (VAS) score during the past 2 weeks. Headache was measured with VAS and the Headache Impact Test (HIT-6) questionnaire. At baseline, females reported more pain sites (4.7) than males (3.4), and only 7% reported no pain in the past 2 weeks. During the past 4 weeks, 63% reported headache with a high mean HIT-6 score of 60 (SD 7). At follow-up, vitamin D level, measured as serum 25(OH)D3, increased from 27 nmol/L to 52 nmol/L and from 27 nmol/L to 43 nmol/L in the 25-µg and 10-µg supplementation groups, respectively, whereas serum 25(OH)D3 did not change in the placebo group. Pain scores and headache scores were improved at follow-up compared with baseline. The use of vitamin D supplements, however, showed no significant effect on the occurrence, anatomical localization, and degree of pain or headache compared to placebo.

Does vitamin D improve muscle strength in adults? A randomized, double-blind, placebo-controlled trial among ethnic minorities in Norway.

CONTEXT: The effect of vitamin D on muscle strength in adults is not established. OBJECTIVE: Our objective was to test whether vitamin D supplementation increases muscle strength and power compared with placebo. DESIGN: We conducted a randomized, double-blind, placebo-controlled trial. SETTING: The setting was immigrants' activity centers. PARTICIPANTS: Two hundred fifty-one healthy adult males and females aged 18-50 years with non-Western immigrant background performed the baseline test and 86% returned to the follow-up test. INTERVENTIONS: Sixteen weeks of daily supplementation with 25 µg (1000 IU) vitamin D3, 10 µg (400 IU) vitamin D3, or placebo. MAIN OUTCOME MEASURES: Difference in jump height between pre- and postintervention. Secondary outcomes were differences in handgrip strength and chair-rising test. RESULTS: Percentage change in jump height did not differ between those receiving vitamin D (25 or 10 µg vitamin D3) and those receiving placebo (mean difference -1.4%, 95% confidence interval: -4.9% to 2.2%, P=.44). No significant effect was detected in the subgroup randomized to 25 µg vitamin D or in other preplanned subgroup analyses nor were there any significant differences in handgrip strength or the chair-rising test. Mean serum 25-hydroxyvitamin D3 concentration increased from 27 to 52 nmol/L and from 27 to 43 nmol/L in the 25 and 10 µg supplementation groups, respectively, whereas serum 25-hydroxyvitamin D3 did not change in the placebo group. CONCLUSIONS: Daily supplementation with 25 or 10 µg vitamin D3 for 16 weeks did not improve muscle strength or power measured by the jump test, handgrip test, or chair-rising test in this population with low baseline vitamin D status.