A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes
Background & aims: This participant-blinded parallel-group randomized placebo-controlled study demonstrated that alfacalcidol (vitamin D analogue) preserves beta cell function in newly diagnosed type 1 diabetes (T1DM) in children. Methods: Subjects from outpatient clinic were randomized to inte...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier BV
2013
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| Online Access: | http://psasir.upm.edu.my/id/eprint/29701/ http://psasir.upm.edu.my/id/eprint/29701/1/A%20randomized%20placebo.pdf |
| _version_ | 1848846472073707520 |
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| author | Asal, Ataie Jafari Loke, Seng Cheong Rahmat, Asmah Larijani, Bagher Abbasi, Farzaneh Leow, Melvin Khee Shing Yassin, Zaitun |
| author_facet | Asal, Ataie Jafari Loke, Seng Cheong Rahmat, Asmah Larijani, Bagher Abbasi, Farzaneh Leow, Melvin Khee Shing Yassin, Zaitun |
| author_sort | Asal, Ataie Jafari |
| building | UPM Institutional Repository |
| collection | Online Access |
| description | Background & aims: This participant-blinded parallel-group randomized placebo-controlled study demonstrated that alfacalcidol (vitamin D analogue) preserves beta cell function in newly diagnosed type 1 diabetes (T1DM) in children.
Methods: Subjects from outpatient clinic were randomized to intervention and control groups. Inclusion: (1) age 8–15, (2) T1DM, (3) duration <8 weeks, (4) no chronic diseases, (5) stable diet. Exclusion: (1) vitamin D, calcium supplements or fortified foods, (2) hypercalcemia. Intervention group received alfacalcidol 0.25 μg twice daily, while control group received placebo. Insulin given physician-titrated to blood glucose. Safety monitored by serum calcium and phosphate. Beta cell function assessed at 0, 3, 6 months using fasting C-peptide (FCP) and daily insulin dosage per body weight (DID). Primary outcome measured using multivariate repeated measures GLM-ANOVA, with FCP and DID as primary measures and age, gender, sunlight exposure, 25-hydroxy vitamin D, and HbA1c as covariates.
Results: Of 61 subjects, 7 dropped out. GLM-ANOVA showed that groups were different (p = 0.019, Eta-squared = 0.087), with no significant covariates. FCP was higher and DID lower in the intervention group, with males having stronger responses to alfacalcidol (p = 0.001). No adverse effects were observed.
Conclusions: The study confirmed that alfacalcidol can safely preserve beta cell function in newly diagnosed T1DM in children, with a stronger effect in males. |
| first_indexed | 2025-11-15T09:03:15Z |
| format | Article |
| id | upm-29701 |
| institution | Universiti Putra Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-15T09:03:15Z |
| publishDate | 2013 |
| publisher | Elsevier BV |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | upm-297012015-09-02T04:54:49Z http://psasir.upm.edu.my/id/eprint/29701/ A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes Asal, Ataie Jafari Loke, Seng Cheong Rahmat, Asmah Larijani, Bagher Abbasi, Farzaneh Leow, Melvin Khee Shing Yassin, Zaitun Background & aims: This participant-blinded parallel-group randomized placebo-controlled study demonstrated that alfacalcidol (vitamin D analogue) preserves beta cell function in newly diagnosed type 1 diabetes (T1DM) in children. Methods: Subjects from outpatient clinic were randomized to intervention and control groups. Inclusion: (1) age 8–15, (2) T1DM, (3) duration <8 weeks, (4) no chronic diseases, (5) stable diet. Exclusion: (1) vitamin D, calcium supplements or fortified foods, (2) hypercalcemia. Intervention group received alfacalcidol 0.25 μg twice daily, while control group received placebo. Insulin given physician-titrated to blood glucose. Safety monitored by serum calcium and phosphate. Beta cell function assessed at 0, 3, 6 months using fasting C-peptide (FCP) and daily insulin dosage per body weight (DID). Primary outcome measured using multivariate repeated measures GLM-ANOVA, with FCP and DID as primary measures and age, gender, sunlight exposure, 25-hydroxy vitamin D, and HbA1c as covariates. Results: Of 61 subjects, 7 dropped out. GLM-ANOVA showed that groups were different (p = 0.019, Eta-squared = 0.087), with no significant covariates. FCP was higher and DID lower in the intervention group, with males having stronger responses to alfacalcidol (p = 0.001). No adverse effects were observed. Conclusions: The study confirmed that alfacalcidol can safely preserve beta cell function in newly diagnosed T1DM in children, with a stronger effect in males. Elsevier BV 2013-12 Article PeerReviewed application/pdf en http://psasir.upm.edu.my/id/eprint/29701/1/A%20randomized%20placebo.pdf Asal, Ataie Jafari and Loke, Seng Cheong and Rahmat, Asmah and Larijani, Bagher and Abbasi, Farzaneh and Leow, Melvin Khee Shing and Yassin, Zaitun (2013) A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes. Clinical Nutrition, 32 (6). pp. 911-917. ISSN 0261-5614; ESSN: 1532-1983 10.1016/j.clnu.2013.01.012 |
| spellingShingle | Asal, Ataie Jafari Loke, Seng Cheong Rahmat, Asmah Larijani, Bagher Abbasi, Farzaneh Leow, Melvin Khee Shing Yassin, Zaitun A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| title | A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| title_full | A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| title_fullStr | A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| title_full_unstemmed | A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| title_short | A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| title_sort | randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes |
| url | http://psasir.upm.edu.my/id/eprint/29701/ http://psasir.upm.edu.my/id/eprint/29701/ http://psasir.upm.edu.my/id/eprint/29701/1/A%20randomized%20placebo.pdf |