Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents
CAL-D
Effect of Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among Perinatally HIV-infected Children and Adolescents
1 other identifier
interventional
200
1 country
5
Brief Summary
Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long. Some of the HIV medications can negatively impact the health of the bone and is even more exacerbated in perinatally HIV-injected children and adolescents because this is the period when the bone peaks. Bone loss during this period can be devastating and increase the risk for developing weak bones later in life. Supplementation of calcium and vitamin D have not been well studied in HIV-infected children and adolescents in developing countries. Therefore it is not clear whether higher doses of these supplementations can thwart the damages or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2015
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 8, 2019
August 1, 2019
3.8 years
April 22, 2015
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
lumbar spine Bone Mineral Density (BMD)
To compare the changes in lumbar spine BMD in perinatally HIV-infected children and adolescents receives 48-week of calcium and high-dose vitamin D supplementation with that of children and adolescents receiving 48-week of calcium and normal dose vitamin D supplementation.
48 weeks
Study Arms (2)
High dose vitamin D and calcium
EXPERIMENTALFixed-dose combination (FDC) of 1,500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3, administered orally twice daily plus vitamin D2 (20,000 IU/cap) administered once weekly (a total of 1,200 mg of elemental calcium and 3,200 IU of vitamin D daily)
Normal dose vitamin D and calcium
ACTIVE COMPARATORFixed-dose combination (FDC) of 1,500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3, administered orally twice daily (a total of 1,200 mg of elemental calcium and 400 IU of vitamin D daily)
Interventions
participants will receive a FDC tablet containing 1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3. This drug will be administered as 1 tablet orally twice daily and is to be taken with food. In addition, participants will receive vitamin D2 capsule containing 20,000 IU of ergocalciferol, which will be administered as 1 capsule orally once weekly at any time (not related with meal).
participants will receive a FDC tablet containing 1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3. This drug will be administered as 1 tablet orally twice daily and is to be taken with food
Eligibility Criteria
You may qualify if:
- Participants age 10-20 years.
- Have a history and/or medical record of HIV infection.
- Have a history and/or medical record and/or maternal HIV status confirmed of perinatally acquired HIV infection.
- Have virological suppression after receiving ART, defined as plasma HIV RNA less than 400 copies/mL within 12 months prior to screening.
- Participants who had been evaluated for BMD (have BMD result) within 1 year prior to entry visit.
- Caregivers and/or participants gives written inform consent/assent form.
You may not qualify if:
- Participants who have a documented history of bone fracture at any time prior to screening.
- Participants who have received any form of calcium greater than 1000 mg/day of elemental calcium at least once within 6 months prior screening.
- Participants who have received any form of vitamin D (e.g., ergocalciferol or cholecalciferol) supplementation greater than 400 IU/day at least once within 6 months prior to screening.
- Participants who have received any past pharmacologic treatment for low bone density or osteoporosis (e.g., alendronate) at any time prior to screening.
- Participants who have a documented history of growth hormone deficiency at any time or using growth hormone within 6 months prior to screening.
- Participants who have a documented history of primary hyperparathyroidism, hypoparathyroidism, or cushing syndrome at any time prior to screening.
- Participants who have a documented prior history of kidney stone, renal failure, or renal function impairment (serum creatinine \>2 mg/dL).
- Participants who have a documented prior history of chronic active liver diseases, or liver impairment (alanine aminotransferase \[ALT\] \>100 IU/L at least 2 times within 6 months).
- Participants who have a documented prior history of thalassemia major (homozygous β-Thalassemia or β-Thalassemia/Hemoglobin E) or sickle cell disease.
- Participants use any oral, intravenous, or inhaled steroids within 6 months prior to study entry (intranasal steroid use is allowed).
- Participants who have received anticonvulsant medications (phenytoin, phenobarbital, carbamazepine), methotrexate, within 6 months prior to screening.
- Pregnancy or breast feeding
- Participants who have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiang Mai Universitylead
- HIV-NAT, Thai Red Cross - AIDS Research Centrecollaborator
- Nakornping Hospitalcollaborator
Study Sites (5)
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, 10330, Thailand
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
Faculty of Medicine and Research Institute for Health Sciences (RIHES), Chiang Mai University
Chiang Mai, 50200, Thailand
Nakornping hospital (NKP)
Chiang Mai, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, 50700, Thailand
Related Publications (1)
Sudjaritruk T, Bunupuradah T, Aurpibul L, Kanjanavanit S, Chotecharoentanan T, Sricharoen N, Ounchanum P, Suntarattiwong P, Pornpaisalsakul K, Puthanakit T; CAL-D Study Group. Impact of Vitamin D and Calcium Supplementation on Bone Mineral Density and Bone Metabolism Among Thai Adolescents With Perinatally Acquired Human Immunodeficiency Virus (HIV) Infection: A Randomized Clinical Trial. Clin Infect Dis. 2021 Nov 2;73(9):1555-1564. doi: 10.1093/cid/ciab547.
PMID: 34125899DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tavitiya Sudjaritruk, MD
Chiang Mai University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 27, 2015
Study Start
April 1, 2015
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
August 8, 2019
Record last verified: 2019-08