Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents (CAL-D)

August 7, 2019 updated by: Tavitiya Sudjaritruk, Chiang Mai University

Effect of Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among Perinatally HIV-infected Children and Adolescents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adverse bone health is one of the major long-term complications among perinatally HIV-infected children and adolescents receiving ART. Since a great deal of bone mineral accrual occurs during the adolescent years and the peak attainment is usually seen at age 18 years, the loss of bone deposition during this period could lead to serious consequences, particularly increased risk of osteoporosis and bone fragility in later of life. A previous study demonstrated that prevalence of low BMD among perinatally HIV-infected Thai children and adolescents was high (25%). However, the prevention strategies such as calcium and vitamin D supplementation which are widely recommended by many guidelines for preventing of osteoporosis and bone fracture have not been well studied to prove their effectiveness among HIV-infected children and adolescents, especially in resource-limited countries. This is considered as the critical research question in pediatric HIV/AIDS field which are urgently required robust and in-depth investigations.

This randomized clinical trial study will provide important information about the effect of calcium and high dose (comparing to normal dose) vitamin D supplementation on BMD among ART-experienced, perinatally acquired HIV-infected children and adolescents to best understand the relative contributions of the supplementation to improve bone health status. This study will address research questions, fill gaps in knowledge, and draw clinician attentions to the important long-term medical complications in children and adolescents who are growing up with HIV. Moreover, this study will inform healthcare providers and policy makers about the importance of calcium and vitamin D supplementation as one of the measurement to prevent long-term deterioration of bone mass and the mean to promote bone health among these populations.

The funding for this study is the National Research University, Chiang Mai University.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Queen Sirikit National Institute of Child Health
      • Bangkok, Thailand, 10330
        • HIV-NAT, Thai Red Cross - AIDS Research Centre
      • Chiang Mai, Thailand, 50200
        • Faculty of Medicine and Research Institute for Health Sciences (RIHES), Chiang Mai University
      • Chiang Mai, Thailand
        • Nakornping hospital (NKP)
      • Chiang Rai, Thailand, 50700
        • Chiangrai Prachanukroh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose vitamin D and calcium
Fixed-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)
Dietary supplement: High dose vitamin D and calcium
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).
Active Comparator: Normal dose vitamin D and calcium
Fixed-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)
Dietary supplement: Normal dose vitamin D and calcium
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lumbar spine Bone Mineral Density (BMD)
Time Frame: 48 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Collaborators

Nakornping Hospital
HIV-NAT, Thai Red Cross - AIDS Research Centre

Investigators

  • Principal Investigator: Tavitiya Sudjaritruk, MD, Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAL-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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